Office Action 1: Non-Final Rejection (2024-07-17)
Rejection types: 112 - Written Description/Enablement

CLAIMS:
Qun WANG Application No. 17/819,199 Amendments to the Claims

This listing of claims will replace all prior versions, and listings, of claims in the application.

1\. (Original) An isolated antigen binding protein that specifically binds to Klebsiellapneumoniae 02 antigen, wherein said antigen binding protein induces opsonophagocytic killing (OPK) of Klebsiella.

2\. - 67. (Canceled) 366

68\. (Currently Amended) An isolated nucleic acid molecule encoding the antigen binding protein thereof according to claim 1 .

69-73. (Canceled) 7072

74\. (Currently Amended) A hybridoma producing the antigen binding protein of claim l .

75\. - 84. (Canceled) 7683

85\. (Currently Amended) A method for treating, preventing, or ameliorating a condition associated with a Klebsiella infection in a subject in need thereof comprising administering to said subject an effective amount of \[\[the\]\] an antigen binding protein that specifically binds to Klebsiellapneumoniae 02 antigen and comprises a set of Complementarity-Determining Regions (CDRs): HCDRI, HCDR2, HCDR3, LCDRI, LCDR2, and LCDR3 wherein the H-CDRI, H-CDR2, HCDR3, LCDRI, LCDR2, and
LCDR3 comprise the amino acid sequences of:
SEQ. ID. NOs: 10-13, 14 or 15, and 16, respectively;
SEQ. ID. NOs: 19-22, 23 or 24, and 25, respectively; -4- Qun WANG Application No. 17/819,199 SEQ. ID. NOs: 28-31, 32 or 33, and 34, respectively,
SEQ. ID. NOs: 37-40, 41 or 42, and 43, respectively:
SEQ. ID. NOs: 46-49, 50 or 51, and 52, respectively:
SEQ. ID. NOs: 166-168, 175, 176 or 177, and 178, respectively, SEQ. ID. NOs: 169-171, 179, 180 or 181, and 182, respectively;
SEQ. ID. NOs: 55-58, 59 or 60, and 61, respectively:
SEQ. ID. NOs: 64-67, 68 or 69, and 70, respectively:
SEQ. ID. NOs: 73-78, respectively;
SEQ. ID. NOs: 82-85, 86 or 87, and 88, respectively:
SEQ. ID. NOs: 91-94, 95 or 96, and 97, respectively:
SEQ. ID. NOs: 100-103, 104 or 105, and 106, respectively;
SEQ. ID. NOs: 109-112, 113 or 114, and 115, respectively;
SEQ. ID. NOs: 118-121, 122 or 123, and 124, respectively;
SEQ. ID. NOs: 127-130, 131 or 132, and 133, respectively: or
SEQ. ID. NOs: 172-174, 183, 184 or 185, and 186, respectively or
    .

\-5- Qun WANG Application No. 17/819,199

86\. (Currently Amended) A method for inhibiting the growth of Klebsiella, or reducing the number of Klebsiella in a subject infected with Klebsiella comprising administering to a subject in need thereof the antigen binding protein or the pharmaceutical composition of claim l .

87\. - 88. (Canceled)

89\. (Currently Amended) The method of claim 85, wherein the K/ebsiella is antibiotic-resistant.

90\. (Original) The method of claim 89, wherein the Klebsiella is resistant to cephalosporin, quinolone, carbapnem, meroprem, fluoroquinolone, tetracycline, chloramphenicol, trimethoprim, sulfonamide, and/or colistin.

91\. (Original) A method for sensitizing an antibiotic-resistant Klebsiella strain to antibiotics comprising contacting the antibody-resistant Klebsiella strain with an antigen binding protein that that specifically binds to Klebsiella pneumoniae 02 antigen.

92\. (Currently Amended) The method of claim 85 , further comprising administering an antibiotic.

93\. (Original) The method of claim 92, wherein the antigen binding protein and the antibiotic provide a synergistic therapeutic effect.

94\. -95. (Canceled) -6- Qun WANG Application No. 17/819,199

96\. (Currently Amended) The method of claim 92 , wherein the antibiotic is meropenem, carbapenems, fluoroquinolone, tetracycline, chloramphenicol, trimethoprim, sulfonamide, and/or colistin.

97\. (Currently Amended) The method of claim 89 , wherein antigen binding protein also specifically binds Klebsiellapneumoniae 01 antigen.

98\. (Currently Amended) The method of claim 89 , wherein the antigen binding protein that specifically binds to Klebsiellapneumoniae 02 antigen is an antibody or antigen binding fragment thereof.

99\. (Canceled)

100\. (Currently Amended) The method of claim 85 , wherein the Klebsiella is K. pneumoniae, K. oxytoca, K. planticola, K. ozaenae, K. rhinosclermoatis and/or K. granulomatis.

101\. (Original) The method of claim 100, wherein the Klebsiella is K. pneumoniae.

102\. (Currently Amended) The method of claim 85 , , , , , , , wherein the condition is selected from the group consisting of pneumonia, urinary tract infection, septicemia/sepsis, neonatal septicemia/sepsis, dimrhea, soft tissue infection, infection following an organ transplant, surgery infection, wound infection, lung infection, pyogenic liver abscesses (PLA), endophthalmitis, meningitis, necrotizing meningitis, ankylosing spondylitis, nosocomial infection and spondy loarthropathies.

\-7- Qun WANG Application No. 17/819,199

103\. (Currently Amended) The method of claim 85, , , , , , wherein the condition is a nosocomial infection.
Atty. Dkt. No. 2943.1410002 Atty. Dkt. No. 2943.1410002 Atty. Dkt. No. 2943.1410002 Atty. Dkt. No. 2943.1410002

OFFICE ACTION:
Notice of Pre-AIA  or AIA  Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
1.	Applicant’s preliminary amendment filed on November 14, 2022 is acknowledged. Claims 2-67, 69-73, 75-84, 87-88, 94-95 and 99 have been canceled. Claims 68, 74, 85, 86, 89, 92, 96-98, 100 and 102-103 have been amended. Claims 1, 68, 74, 85-86, 89-93, 96-98 and 100-103 are currently pending.
Election/Restriction
2.	Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1 and 74, drawn to an isolated antigen binding protein, classified in C07K2317/565.
II. Claim 68, drawn to an isolated nucleic acid molecule, classified in A61K51/0491.
III. Claims 85, 86, 89, 90, 92, 93, 96-98 and 100-103, drawn to a method for treating, preventing or ameliorating a condition associated with a Klebsiella infection, classified in C07K14/26.
IV. Claim 91, drawn to a method for sensitizing an antibiotic-resistant Klebsiella strain to antibiotics, classified in C07K2317/76.
The inventions are independent or distinct, each from the other because:
Inventions I and II are unrelated.  Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06).  In the instant case, Invention I is drawn to an isolated antigen binding protein, which is completely different from that of invention II which is drawn to an isolated nucleic acid molecule.
Inventions I and II as compared to Inventions III and IV are related as product and process of use.  The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h).  In the instant case Inventions I and II can each be used in a diagnostic assay.
Inventions III and IV are unrelated.  Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06).  In the instant case, Invention III comprises completely different method steps and outcomes as compared to Invention IV.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions above are patentably distinct.  The search for each of the above inventions would not be co-extensive in scope particularly with regard to the literature search.  Burden consists not only of specific searching of Cooperative Patent Classification, classes and subclasses, but also of searching multiple databases for foreign references and literature searches.  Burden also resides in the examination of independent claim sets for clarity, enablement, and double patenting issues.  Further, a reference that would anticipate the invention of one group would not necessarily anticipate or even make obvious another group.  Finally, the consideration for patentability is different in each case.  Thus, it would be an undue burden to examine all of the above inventions in one application and the restriction for examination purposes as indicated above is deemed proper.
During a telephone conversation with Cynthia DeRenzo on June 4, 2024 a provisional election was made without traverse to prosecute the invention of Group III, claims 85-86, 89-90, 92-93, 96-98 and 100-103.  Affirmation of this election must be made by applicant in replying to this Office action.  Consequently, claims 1, 68, 74 and 91 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claims 85-86, 89-90, 92-93, 96-98 and 100-103 are currently under examination.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA  35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with  37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Information Disclosure Statement
3.	The information disclosure statement (IDS) submitted on September 20, 2023; June 23, 2023; March 22, 2023 and November 14, 2022 is in compliance with the provisions of 37 CFR 1.97.  Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
Specification
4.	The disclosure is objected to because of the following informalities: the specification contain references to skipped SEQ ID NOs under the new ST.26 rules; see for example SEQ ID Nos: 14, 23, 32, 41, 50, and 176. Disclosures that refer to skipped sequences are improper. SEQ ID NOs containing prohibited sequence types under ST.26 will appear in the sequence listing but will not have sequence data, i.e., appear as “000” within the listing. While the sequence listing itself may contain a skipped sequence, reference to a “skipped” sequence within the disclosure is improper. Applicant is encouraged to review the entire specification and to remove any reference to the relevant SEQ ID NO from the specification.  Appropriate correction is required.
5.	The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code; see for example paragraph 0119. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
6.	Claim 85 and 102 are objected to because of the following informalities: As it pertains to claim 85, the claim contain references to skipped SEQ ID NOs under the new ST.26 rules; see for example SEQ ID Nos: 14, 23, 32, 41, 50, and 176. A reference to skipped sequences are improper. SEQ ID NOs containing prohibited sequence types under ST.26 will appear in the sequence listing but will not have sequence data, i.e., appear as “000” within the listing. While the sequence listing itself may contain a skipped sequence, reference to a “skipped” sequence within the claim is improper. Appropriate correction is required.
As it pertains to claim 102, the word dimrhea should be diarrhea. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA  35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
7.	Claims 85, 89-90, 92-93, 96-98 and 100-103 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA  35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 85 is drawn to a method for treating, preventing, or ameliorating a condition associated with a Klebsiella infection in a subject in need thereof comprising administering to said an effective amount of an antigen binding protein that specifically binds to Klebsiella pneumoniae 02 antigen and comprises a set of Complementarity-Determining Regions (CDRs): HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of: SEQ. ID. NOs: 10-13, 14 or 15, and 16, respectively; SEQ. ID. NOs: 19-22, 23 or 24, and 25 respectively; SEQ. ID. NOs: 28-31, 32 or 33, and 34, respectively; SEQ. ID. NOs: 37-40, 41 or 42, and 43, respectively; SEQ. ID. NOs: 46-49, 50 or 51, and 52, respectively; SEQ. ID. NOs: 166-168,175, 176 or 177, and 178 respectively; SEQ. ID. NOs: 169-171, 179, 180 or 181, and 182, respectively; SEQ. ID. NOs: 55-58, 59 or 60, and 61, respectively; SEQ. ID. NOs: 64-67, 68 or 69, and 70 respectively; SEQ. ID. NOs: 73-78, respectively; SEQ. ID. NOs: 82-85, 86 or 87, and 88, respectively; SEQ. ID. NOs: 91-94, 95 or 96, and 97, respectively; SEQ. ID. NOs: 100-103, 104 or 105, and 106, respectively; SEQ. ID. NOs: 109-112, 113 or 114, and 115, respectively; SEQ. ID. NOs: 118-121, 122 or 123, and 124, respectively; SEQ. ID. NOs: 127-130, 131 or 132, and 133, respectively; or SEQ. ID. NOs: 172-174, 183, 184 or 185, and 186, respectively.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus of conditions associated with a Klebsiella infection in a subject or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession of the claimed invention.  In the instant case, to fulfill the written description requirement, a representative number of conditions associated with a Klebsiella infection to be treated, prevented or ameliorated using an antigen binding protein that specifically binds to Klebsiella pneumoniae 02 antigen and comprises a set of Complementarity-Determining Regions (CDRs) as claimed must be described.
A representative number of species means that the species that are adequately described are representative of the entire genus.  The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the claimed genus.
The specification describes ( Tables 3, 4 and 7) antigen binding protein (i.e., KPS 44 monoclonal antibody) which specifically bind to Klebsiella pneumoniae 02 antigen having opsonophagocytic killing (OPK) of O2 strain of  Klebsiella pneumoniae (figures 10A-C and 11A) having VH and VL set forth as SEQ. ID. NO: 116 and SEQ ID NO:117, said  antigen binding protein comprising a set of Complementarity-Determining Regions (CDRs): HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprising the amino acid sequences of 109, 110, 111, 112, 114, and 115, respectively (Table 1 and 2). However, the specification has not adequately described methods of treating, preventing and ameliorating all conditions associated with a Klebsiella infections generally or by using the composition as claimed.
As it pertains to prevention, to be a prophylactic method the composition as claimed, once administered must induce a protective immune response demonstrated by challenge experiments in an acceptable animal model. The specification does not provide substantive evidence that the broadly claimed method is capable of inducing protective immunity. This demonstration is required for the skilled artisan to be able to use the claimed composition for their intended potential purpose of prevention. Without this demonstration, the skilled artisan would not be able to reasonably predict the outcome of the administration of the claimed composition, i.e. would not be able to accurately predict if protective immunity has been induced.
It is clear the specification does not adequately describe the methods as claimed as there are no examples geared towards the methods as claimed. This demonstration is extremely important and is done by adequately providing the means and effectiveness of the claimed composition as it pertains to conditions associated with a Klebsiella infection, so much so that a skilled artisan could readily be aware of it without undue burden and could administer said composition for the methods as claimed with some modicum of success.
As it pertains to the state of the prior art, CDC, https://www.cdc.gov/klebsiella/about/index.html#:~:text=Klebsiella%20is%20a%20type%20of,becoming%20increasingly%20resistant%20to%20antibiotics.; accessed on July 11, 2024 teaches that Klebsiella is a type of bacteria normally found in human stool (feces) that can cause healthcare-associated infections (HAIs), pneumonia, bloodstream infections, wound or surgical site infections, and meningitis. As it pertains to prevention, patients should clean their hands often, including:
Before preparing or eating food.
Before touching their eyes, nose or mouth.
Before and after changing wound dressings or bandages.
After using the restroom.
After blowing their nose, coughing or sneezing.
After touching hospital surfaces such as bed rails, bedside tables, doorknobs, remote controls or the phone.
As it pertains to treatment, Klebsiella infections are generally treated with antibiotics. Unfortunately, some Klebsiella bacteria (germs) are resistant to multiple antibiotics, which makes them difficult to treat.
Moreover, Healthline, https://www.healthline.com/health/klebsiella-pneumonia#infection-symptoms; accessed on July 11, 2024 teaches that K. pneumoniae can infect different parts of your body, it can cause different types of infections with different symptoms. K. pneumoniae often causes bacterial pneumonia, or infection in your lungs. It happens when the bacteria enter your respiratory tract. Community acquired pneumonia occurs if you contract it in a community setting, like a mall or subway. Hospital acquired pneumonia occurs if you contract it at a hospital or nursing home. In Western countries, K. pneumoniae causes about 3 to 5 percent of community acquired pneumonia. It’s also responsible for 11.8 percent of hospital acquired pneumonia worldwide. Symptoms of pneumonia include: fever, chills, coughing, yellow or bloody mucus, shortness of breath, and chest pain
If K. pneumoniae gets in your urinary tract, it can cause a UTI. Your urinary tract includes your urethra (the tube that allows urine to pass out of your body), bladder, ureters (the tube that carries urine from your kidneys to your bladder), and kidneys. Klebsiella UTIs occur when the bacteria enter your urinary tract. Though it can affect anyone, you have a higher chance if you:
have a urinary catheter in place, which is a tube placed in your body to drain and collect urine from your bladder
are a person with a uterus
are living with kidney disease
UTIs don’t always cause symptoms. If you do have symptoms, you might experience:
frequent urge to urinate
pain and burning when urinating
bloody or cloudy urine
passing small amounts of urine
pain in your back or pelvic area
discomfort in your lower abdomen
fever
If you have a UTI in your kidneys, you might have:
fever
chills
nausea
vomiting
pain in your upper back and side
You can experience an upper or a lower UTI. Both have similar symptoms, but upper UTIs will often entail more systemic symptoms and are typically more severe than lower UTIs. Most people with a UTI will have symptoms. If you don’t have symptoms, you probably don’t have a UTI. You probably have an abnormal urine test with results that look like you have a UTI.
If K. pneumoniae enters through a break in your skin, it can infect your skin or soft tissue. Usually, this happens with wounds caused by surgery or injury. K. pneumoniae wound infections include: cellulitis, necrotizing fasciitis, myositis. Depending on your type of infection, you might experience:
fever
redness
swelling
pain
flu-like symptoms
fatigue
wounds or ulcers, which are sores on the lining of your stomach, small intestine, or esophagus
In rare cases, K. pneumoniae can cause bacterial meningitis, or inflammation of the membranes that cover your brain and spinal cord. This happens when bacteria infect the fluid around your brain and spinal cord. Most cases of K. pneumoniae meningitis happen in hospital settings. Generally, meningitis causes a sudden onset of:
high fever
headache
stiff neck
Other symptoms may include:
nausea
vomiting
photophobia (sensitivity to light)
confusion
seizures (although rare)
If K. pneumoniae is in your blood, it can spread to your eyes and cause endophthalmitis. This is an infection that causes inflammation in the white of your eye and can lead to blindness. This type of endophthalmitis is rare in Western countries. Symptoms may include:
eye pain
redness
white or yellow discharge
white cloudiness on the cornea
photophobia
blurred vision
In recent years, the number of people who have developed a pyogenic liver abscess due to K. pneumoniae in the United States has increased. K. pneumoniae liver abscesses commonly affect people with diabetes or an alcohol use disorder or who have been taking antibiotics for a long time. Common symptoms include:
fever
pain in the upper right of your abdomen
nausea
vomiting
diarrhea
If K. pneumoniae enters your blood, it can cause bacteremia, or the presence of bacteria in your blood. In primary bacteremia, K. pneumoniae directly infects your bloodstream. In secondary bacteremia, K. pneumoniae spreads to your blood from an infection somewhere else in your body. In one 2016 study, researchers estimated that about 50 percent of Klebsiella blood infections originate from Klebsiella infection in the lungs. Symptoms usually develop suddenly. This might include: fever, chills and shaking. Bacteremia needs to be treated immediately. If left untreated, bacteremia can become life threatening and turn into sepsis, which is when your body has an extreme response to an infection.
Written description requirement must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.  The invention is, for purposes of the written description inquiry, whatever is now claimed. The Guidelines further state, [f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus.
Therefore, absent a detailed and particular description of a representative number, or at least a substantial number of the genus of probiotics and enzymes as related to the disorders as claimed, the skilled artisan could not immediately recognize or distinguish members of the claimed genus. Therefore, because the art is unpredictable, in accordance with the Guidelines, the description of a particular derivative is not deemed representative of the genus of immunogenic compositions to which the claims refer and hence do not meet the written description requirements.
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that:  ...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention.   Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997);   In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ( [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.). Thus, an applicant complies with the written description requirement by describing the invention, with all its claimed limitations, not that which makes it obvious, and by using such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.  Lockwood, 107 F.3d at 1572, 41 USPQ2datl966.
Conclusion
8.	No claim is allowed.
9.

APPLICANT REBUTTAL: Remarks
Reconsideration of this Application is respectfully requested.
Upon entry of the foregoing amendment, claims 1, 68, 85-86, 89-93, 96-98, 100, 101, and 104-107 are pending in the application, with claims 1, 85, and 91 being the independent claims. Claims 1, 68, and 91 are withdrawn. Claims 85, 86, and 90 are sought to be amended. Claims 74, 102, and 103 are sought to be canceled without prejudice to or disclaimer of the subject matter therein. New claims 104-107 are sought to be added. The specification has also been amended as discussed below. These changes are believed to introduce no new matter, and their entry is respectfully requested.
Based on the above amendment and the following remarks, Applicants respectfully request that the Examiner reconsider all outstanding objections and rejections and that they be withdrawn.
Election/Restriction
The Office requires restriction to one of four identified Groups of claims (Groups I-IV).
Office Action at page 2. Applicants confirm election of the invention of Group III, represented by claims 85, 86, 89, 90, 92, 93, 96-98, and 100-101 (as well as new claims 104-107).
Objection to the Specification
The Specification is objected to because the specification allegedly contains references to skipped SEQ ID NOs under the new ST.26 rules. Office Action at page 6. Without acquiescing to the propriety of the objections and solely to expedite prosecution, the specification has been amended to remove references to skipped SEQ ID NOs.
The specification is also objected to for containing an embedded hyperlink and/or other form of browser-executable code. Office Action at page 7. Without acquiescing to the propriety of the objections and solely to expedite prosecution, the specification has been amended to remove embedded hyperlinks and/or other forms of browser-executable code.
Accordingly, Applicants respectfully request that the objections to the specification be withdrawn.
Objection to the Claims
Claim 85 and 102 are objected to for containing references to skipped SEQ ID NOs under the new ST.26 rules. Without acquiescing to the propriety of the objections and solely to expedite prosecution, i) claim 85 is sought to be amended to remove references to skipped SEQ ID NOs, and ii) claim 102 has been canceled, mooting the rejection with respect to that claim.
Accordingly, Applicants respectfully request that the objection to the claims be withdrawn.
Rejection under 35 U.S.C. § 112(a)
Claims 85, 89-90, 92, 93, 96-98 and 100-103 are rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, as allegedly failing to comply with the written description requirement. According to the Office Action, the specification has "not adequately described methods of treating, preventing and ameliorating all conditions associated with a [sic] Klebsiella infections generally or by using the composition as claimed." Office Action at page 10. The Office Action also alleges that the "specification does not provide substantive evidence that the broadly claimed method is capable of inducing protective immunity," which the Examiner argues is required for the "intended potential purpose of prevention." Id. Without acquiescing to the
propriety of the objections and solely to expedite prosecution, i) claim 85 has been amended to remove the term "preventing" and to be directed to a method for treating or ameliorating a Klebsiella infection, and ii) claims 102-103 have been canceled, mooting the rejection with respect to those claims. Accordingly, Applicants respectfully request that the written description rejection of the claims be withdrawn.
Conclusion

NEXT OFFICE ACTION: Notice of Pre-AIA  or AIA  Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
1.	Applicant’s response filed on October 17, 2024 is acknowledged.  Claims 1, 68, 85, 86, 89-93, 96-98, 100, 101 and 104-107 are currently pending. Claims 85, 86, and 90 have been amended. Claims 74, 102 and 103 have been canceled. Claims 104-107 have been added.  Claims 1, 68 and 91 were previously withdrawn.  Claims 85, 86, 89, 90, 92, 93, 96-98, 100, 101 and 104-107 are currently under examination.
Allowable Subject Matter
2.    This application is in condition for allowance except for the presence of claims 1, 68 and 91,  directed to an isolated antigen binding protein (claim 1), an isolated nucleic acid molecules (claim 68) and a method for sensitizing an antibiotic-resistant Klebsiella strain (claim 91), which is non-elected without traverse.  Accordingly, claims 1, 68 and 91 have been cancelled. Claims 85, 86, 89, 90, 92, 93, 96-98, 100, 101 and 104-107 are allowed.
Amendment
3.    An Examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
The application has been amended as follows:
In the claims:
Claims 1, 68 and 91 have been cancelled.
4.	Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance”.
5.