Source: http://drugpatentsint.blogspot.in/search/label/Specification
Timestamp: 2017-07-27 21:12:05
Document Index: 723699171

Matched Legal Cases: ['§ 112', '§ 112', '§ 112', '§ 112', '§ 14', '§ 18', '§ 33', '§ 112', '§ 112', '§ 112', '§ 112', '§ 112', '§ 112', '§ 112']

Drug Patents International: Specification
What is 35 U.S. Code § 112 – Specification, ………..it is so easy to understand, try
U.S. Code› Title 35 › Part II › Chapter 11 › § 112………more explanation see below
Law is easy, …. learn with me and explained by cornell
I picked this up from site………..http://www.law.cornell.edu/uscode/text
thanks to cornell
U.S. Code: Table of Contents U.S. Code›
U.S. Code: Title 35 – PATENTS Title 35 ›
35 U.S. Code Part II – PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS Part II ›
35 U.S. Code Chapter 11 – APPLICATION FOR PATENT Chapter 11 ›
§ 112. specification explained in this article
http://www.uspto.gov/web/offices/pac/mpep/mpep-9015-appx-l.html
(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.
(b) Conclusion.— The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
(c) Form.— A claim may be written in independent or, if the nature of the case admits, in dependent or multiple dependent form.
(d) Reference in Dependent Forms.— Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(e) Reference in Multiple Dependent Form.— A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered.
SO EASY TO UNDERSTAND 35 U.S.C. § 112
[Editor Note: Applicable to any patent application filed on or after September 16, 2012. See 35 U.S.C. 112 (pre-AIA)for the law otherwise applicable.]
35 U.S.C. 112 (pre-AIA) Specification.
[Editor Note: Not applicable to any patent application filed on or after September 16, 2012. See 35 U.S.C. 112 for the law otherwise applicable.]
(Amended July 24, 1965, Public Law 89-83, sec. 9, 79 Stat. 261; Nov. 14, 1975, Public Law 94-131, sec. 7, 89 Stat. 691.)
35 U.S.C. 1 – Establishment.
35 U.S.C. 2 – Powers and duties.
35 U.S.C. 3 – Officers and employees.
35 U.S.C. 4 – Restrictions on officers and employees as to interest in patents.
35 U.S.C. 5 – Patent and Trademark Office Public Advisory Committees.
35 U.S.C. 6 – Patent Trial and Appeal Board.
35 U.S.C. 6 (pre-AIA) – Board of Patent Appeals and Interferences.
35 U.S.C. 7 – Library.
35 U.S.C. 8 – Classification of patents.
35 U.S.C. 9 – Certified copies of records.
35 U.S.C. 10 – Publications.
35 U.S.C. 11 – Exchange of copies of patents and applications with foreign countries.
35 U.S.C. 12 – Copies of patents and applications for public libraries.
35 U.S.C. 13 – Annual report to Congress.
35 U.S.C. 21 – Filing date and day for taking action.
35 U.S.C. 22 – Printing of papers filed.
35 U.S.C. 23 – Testimony in Patent and Trademark Office cases.
35 U.S.C. 24 – Subpoenas, witnesses.
35 U.S.C. 25 – Declaration in lieu of oath.
35 U.S.C. 26 – Effect of defective execution.
35 U.S.C. 31 – [Repealed].
35 U.S.C. 32 – Suspension or exclusion from practice.
35 U.S.C. 33 – Unauthorized representation as practitioner.
35 U.S.C. 41 – Patent fees; patent and trademark search systems.
35 U.S.C. 42 – Patent and Trademark Office funding.
35 U.S.C. 100 (note) – AIA First inventor to file provisions.
35 U.S.C. 100 – Definitions.
35 U.S.C. 100 (pre-AIA) – Definitions.
35 U.S.C. 101 – Inventions patentable.
35 U.S.C. 102 – Conditions for patentability; novelty.
35 U.S.C. 102 (pre-AIA) – Conditions for patentability; novelty and loss of right to patent.
35 U.S.C. 103 – Conditions for patentability; non-obvious subject matter.
35 U.S.C. 103 (pre-AIA) – Conditions for patentability; non-obvious subject matter.
35 U.S.C. 104 – [Repealed.]
35 U.S.C. 104 (pre-AIA) – Invention made abroad.
35 U.S.C. 105 – Inventions in outer space.
35 U.S.C. 111 – Application.
35 U.S.C. 111 (pre-AIA) – Application.
35 U.S.C. 112 – Specification. you are here
35 U.S.C. 112 (pre-AIA) – Specification.
35 U.S.C. 113 – Drawings.
35 U.S.C. 114 – Models, specimens.
35 U.S.C. 115 – Inventor’s oath or declaration.
35 U.S.C. 115 (pre-AIA) – Oath of applicant.
35 U.S.C. 116 – Inventors.
35 U.S.C. 116 (pre-AIA) – Inventors.
35 U.S.C. 117 – Death or incapacity of inventor.
35 U.S.C. 118 – Filing by other than inventor.
35 U.S.C. 118 (pre-AIA) – Filing by other than inventor.
35 U.S.C. 119 – Benefit of earlier filing date; right of priority.
35 U.S.C. 119 (pre-AIA) – Benefit of earlier filing date; right of priority.
35 U.S.C. 120 – Benefit of earlier filing date in the United States.
35 U.S.C. 120 (pre-AIA) – Benefit of earlier filing date in the United States.
35 U.S.C. 121 – Divisional applications.
35 U.S.C. 121 (pre-AIA) – Divisional applications.
35 U.S.C. 122 – Confidential status of applications; publication of patent applications.
35 U.S.C. 123 – Micro entity defined.
35 U.S.C. 131 – Examination of application.
35 U.S.C. 132 – Notice of rejection; reexamination.
35 U.S.C. 133 – Time for prosecuting application.
35 U.S.C. 134 – Appeal to the Patent Trial and Appeal Board.
35 U.S.C. 134 (transitional) – Appeal to the Board of Patent Appeals and Interferences.
35 U.S.C. 134 (pre-AIA) – Appeal to the Board of Patent Appeals and Interferences.
35 U.S.C. 135 – Derivation proceedings.
35 U.S.C. 135 (pre-AIA) – Interferences.
35 U.S.C. 141 – Appeal to Court of Appeals for the Federal Circuit.
35 U.S.C. 141 (pre-AIA) – Appeal to the Court of Appeals for the Federal Circuit.
35 U.S.C. 142 – Notice of appeal.
35 U.S.C. 143 – Proceedings on appeal.
35 U.S.C. 143 (pre-AIA) – Proceedings on appeal.
35 U.S.C. 144 – Decision on appeal.
35 U.S.C. 145 – Civil action to obtain patent.
35 U.S.C. 145 (pre-AIA) – Civil action to obtain patent.
35 U.S.C. 146 – Civil action in case of derivation proceeding.
35 U.S.C. 146 (pre-AIA) – Civil action in case of interference.
35 U.S.C. 151 – Issue of patent.
35 U.S.C. 152 – Issue of patent to assignee.
35 U.S.C. 153 – How issued.
35 U.S.C. 154 – Contents and term of patent; provisional rights.
35 U.S.C. 154 (pre-AIA) – Contents and term of patent; provisional rights.
35 U.S.C. 155 – [Repealed.]
35 U.S.C. 155A – [Repealed.]
35 U.S.C. 156 – Extension of patent term.
35 U.S.C. 157 – [Repealed.]
35 U.S.C. 157 (pre-AIA) – Statutory invention registration.
35 U.S.C. 171 – Patents for designs.
35 U.S.C. 172 – Right of priority.
35 U.S.C. 172 (pre-AIA) – Right of priority.
35 U.S.C. 173 – Term of design patent.
35 U.S.C. 181 – Secrecy of certain inventions and withholding of patent.
35 U.S.C. 182 – Abandonment of invention for unauthorized disclosure.
35 U.S.C. 183 – Right to compensation.
35 U.S.C. 184 – Filing of application in foreign country.
35 U.S.C. 184 (pre-AIA) – Filing of application in foreign country.
35 U.S.C. 185 – Patent barred for filing without license.
35 U.S.C. 185 (pre-AIA) – Patent barred for filing without license.
35 U.S.C. 186 – Penalty.
35 U.S.C. 187 – Nonapplicability to certain persons.
35 U.S.C. 188 – Rules and regulations, delegation of power.
35 U.S.C. 200 – Policy and objective.
35 U.S.C. 201 – Definitions.
35 U.S.C. 202 – Disposition of rights.
35 U.S.C. 202 (pre-AIA) – Disposition of rights.
35 U.S.C. 203 – March-in rights.
35 U.S.C. 204 – Preference for United States industry.
35 U.S.C. 205 – Confidentiality.
35 U.S.C. 206 – Uniform clauses and regulations.
35 U.S.C. 207 – Domestic and foreign protection of federally owned inventions.
35 U.S.C. 208 – Regulations governing Federal licensing.
35 U.S.C. 209 – Licensing federally owned inventions.
35 U.S.C. 210 – Precedence of chapter.
35 U.S.C. 211 – Relationship to antitrust laws.
35 U.S.C. 212 – Disposition of rights in educational awards.
35 U.S.C. 251 – Reissue of defective patents.
35 U.S.C. 251 (pre-AIA) – Reissue of defective patents.
35 U.S.C. 252 – Effect of reissue.
35 U.S.C. 253 – Disclaimer.
35 U.S.C. 253 (pre-AIA) – Disclaimer.
35 U.S.C. 254 – Certificate of correction of Patent and Trademark Office mistake.
35 U.S.C. 255 – Certificate of correction of applicant’s mistake.
35 U.S.C. 256 – Correction of named inventor.
35 U.S.C. 256 (pre-AIA) – Correction of named inventor.
35 U.S.C. 257 – Supplemental examinations to consider, reconsider, or correct information.
35 U.S.C. 261 – Ownership; assignment.
35 U.S.C. 262 – Joint owners.
35 U.S.C. 266 – [Repealed.]
35 U.S.C. 267 – Time for taking action in Government applications.
35 U.S.C. 271 – Infringement of patent.
35 U.S.C. 272 – Temporary presence in the United States.
35 U.S.C. 273 – Defense to infringement based on prior commercial use.
35 U.S.C. 281 – Remedy for infringement of patent.
35 U.S.C. 282 – Presumption of validity; defenses.
35 U.S.C. 283 – Injunction.
35 U.S.C. 284 – Damages.
35 U.S.C. 285 – Attorney fees.
35 U.S.C. 286 – Time limitation on damages.
35 U.S.C. 287 – Limitation on damages and other remedies; marking and notice.
35 U.S.C. 288 – Action for infringement of a patent containing an invalid claim.
35 U.S.C. 288 (pre-AIA) – Action for infringement of a patent containing an invalid claim.
35 U.S.C. 289 – Additional remedy for infringement of design patent.
35 U.S.C. 290 – Notice of patent suits.
35 U.S.C. 291 – Derived Patents.
35 U.S.C. 291 (pre-AIA) – Interfering patents.
35 U.S.C. 292 – False marking.
35 U.S.C. 293 – Nonresident patentee; service and notice.
35 U.S.C. 294 – Voluntary arbitration.
35 U.S.C. 295 – Presumption: Product made by patented process.
35 U.S.C. 296 – Liability of States, instrumentalities of States, and State officials for infringement of patents.
35 U.S.C. 297 – Improper and deceptive invention promotion.
35 U.S.C. 298 – Advice of counsel.
35 U.S.C. 299 – Joinder of parties.
35 U.S.C. 301 – Citation of prior art and written statements.
35 U.S.C. 302 – Request for reexamination.
35 U.S.C. 303 – Determination of issue by Director.
35 U.S.C. 304 – Reexamination order by Director.
35 U.S.C. 305 – Conduct of reexamination proceedings.
35 U.S.C. 305 (pre-AIA) – Conduct of reexamination proceedings.
35 U.S.C. 306 – Appeal.
35 U.S.C. 307 – Certificate of patentability, unpatentability, and claim cancellation.
35 U.S.C. 311 (note) – Inter partes review applicability provisions.
35 U.S.C. 311 – Inter partes review.
35 U.S.C. 312 – Petitions.
35 U.S.C. 313 – Preliminary response to petition.
35 U.S.C. 314 – Institution of inter partes review.
35 U.S.C. 315 – Relation to other proceedings or actions.
35 U.S.C. 316 – Conduct of inter partes review.
35 U.S.C. 317 – Settlement.
35 U.S.C. 318 – Decision of the Board.
35 U.S.C. 319 – Appeal.
35 U.S.C. 311 (pre-AIA) – Request for inter partes reexamination.
35 U.S.C. 312 (transitional) – Determination of issue by Director.
35 U.S.C. 313 (transitional) – Inter partes reexamination order by Director.
35 U.S.C. 314 (pre-AIA) – Conduct of inter partes reexamination proceedings.
35 U.S.C. 315 (pre-AIA) – Appeal.
35 U.S.C. 316 (pre-AIA) – Certificate of patentability, unpatentability and claim cancellation.
35 U.S.C. 317 (pre-AIA) – Inter partes reexamination prohibited.
35 U.S.C. 318 (pre-AIA) – Stay of litigation.
35 U.S.C. 321 (note) – Post-grant review applicability.
35 U.S.C. 321 – Post-grant review.
35 U.S.C. 322 – Petitions.
35 U.S.C. 323 – Preliminary response to petition.
35 U.S.C. 324 – Institution of post-grant review.
35 U.S.C. 325 – Relation to other proceedings or actions.
35 U.S.C. 326 – Conduct of post-grant review.
35 U.S.C. 327 – Settlement.
35 U.S.C. 328 – Decision of the Board.
35 U.S.C. 329 – Appeal.
35 U.S.C. 351 – Definitions.
35 U.S.C. 361 – Receiving Office.
35 U.S.C. 362 – International Searching Authority and International Preliminary Examining Authority.
35 U.S.C. 363 – International application designating the United States: Effect.
35 U.S.C. 363 (pre-AIA) – International application designating the United States: Effect.
35 U.S.C. 364 – International stage: Procedure.
35 U.S.C. 365 – Right of priority; benefit of the filing date of a prior application.
35 U.S.C. 366 – Withdrawn international application.
35 U.S.C. 367 – Actions of other authorities: Review.
35 U.S.C. 368 – Secrecy of certain inventions; filing international applications in foreign countries.
35 U.S.C. 371 – National stage: Commencement.
35 U.S.C. 372 – National stage: Requirements and procedure.
35 U.S.C. 373 – [Repealed]
35 U.S.C. 374 – Publication of international application.
35 U.S.C. 374 (pre-AIA – Publication of international application.
35 U.S.C. 375 – Patent issued on international application: Effect.
35 U.S.C. 375 (pre-AIA) – Patent issued on international application: Effect.
35 U.S.C. 376 – Fees.
AIA § 14 (Related to 35 U.S.C. 102, 103) – Tax strategies deemed within the prior art.
AIA § 18 (Related to 35 U.S.C. 321) – Transitional program for covered business method patents.
AIA § 33 (Related to 35 U.S.C. 101) – —Limitation on issuance of patents.
Index INDEX OF PATENT LAWS
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LEARN A CASE STUDY WITH DR ANTHONY, SO EASY TO UNDERSTAND 35 U.S.C. § 112
case study on this
The Attack of 35 U.S.C. § 112
http://www.google.com/patents/US8598219
September 2, 2014, Accord Healthcare, Inc. (“Accord”) filed what appears to be the second-ever Post-Grant Review (“PGR”) (see Petition). This PGR was for U.S. Patent No. 8,598,219 (“the ’219 Patent”), which is jointly assigned to Helsinn Healthcare S.A. and Roche Palo Alto, LLC (collectively “Helsinn”). Helsinn Healthcare Sa, Roche Palo Alto Llc
As a reminder, PGRs are the third type of post-issuance review procedures established by the America Invents Act (“AIA”) — the other two being Inter Partes Review and Covered Business Method Patent Review (IPR and CBM, for short). However, the reason that only one other PGR has been filed to date is because this type of proceeding only applies to patents that were examined pursuant to the new First Inventor to File scheme established by the AIA.
And because such applications could only be filed on or after March 16, 2013, there are only a limited number of such patents that are presently eligible for PGR. One of the other significant differences between IPRs and PGRs is that the latter is not limited to certain types of prior art validity attacks (such as 102 or 103), but instead any type of validity challenge available in District Court is essentially available in front of the Patent Trial and Appeals Board (“PTAB”).
This includes attacks under 35 U.S.C. § 112, such as allegations of a lack of enablement, a lack of written description, and a failure to distinctly claim the invention. Accord took full advantage of this in its petition for PGR2014-00010, in which Accord alleged that Helsinn’s patent related to liquid pharmaceutical formulations of palonosetron should not have been issued by the Patent Office.
The ’219 patent had been asserted in several Hatch-Waxman litigations involving ALOXI®, which is a palonosetron formulation indicated to help prevent nausea and vomiting following chemotherapy. Palonosetron hydrochloride, the active pharmaceutical ingredient, has the following structural formula:
The ’219 patent is a member of a family of patents directed to formulations of palonosetron hydrochloride. Importantly, this patent was filed as a continuation-in-part application on May 23, 2013, with a letter that asserted that claim 9 only had support because of a newly added example, and therefore was subject to the AIA. Only claims 1-5 and 8 of the ’219 patent are the subject of this petition, with claim 1 reading:
CLAIMS(8)………..http://www.google.com/patents/US8598219
2. The pharmaceutical formulation of claim 1, wherein said EDTA is in an amount of 0.5 mg/mL.
3. The pharmaceutical formulation of claim 1, wherein said mannitol is in an amount of 41.5 mg/mL.
4. The pharmaceutical formulation of claim 1, wherein said solution further comprises a citrate buffer.
5. The pharmaceutical formulation of claim 4, wherein said citrate buffer is at a concentration of 20 millimolar.
6. The pharmaceutical formulation of claim 1, wherein said solution is buffered at a pH of 5.0 ±0.5.
7. The pharmaceutical formulation of claim 1, wherein said EDTA is in an amount of 0.5 mg/mL, wherein said mannitol is in an amount of 41.5 mg/mL, wherein said solution further comprises a citrate buffer at a concentration of 20 millimolar, and wherein said solution is buffered at a pH of 5.0 ±0.5.
8. A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising a 5 mL sterile aqueous isotonic solution, said solution comprising:
from 10 mg/mL to 80 mg/mL mannitol, wherein said formulation is stable at 18 months when stored at room temperature.
The petition pointed out that during the prosecution of the ’219 patent and its family, the Patent Office had rejected the claimed formulations as obvious. In response, the applicants submitted a declaration from inventor Daniele Bonadeo (“the Bonadeo declaration”) and argued that one of skill in the art would not have combined the features of the invention as a matter of routine optimization. Instead of routine, the applicants continued, the claimed formulations were obtained after a sequence of experiments, each of which built upon the others like building blocks.
If the experimental sequence had varied, the applicants alleged that they would have obtained a different formulation. The Bonadeo declaration explained that the first two parameters studied were palonosetron concentration and pH. None of the studies described in this declaration, however, occurred at a pH other than 5.0, which makes sense because palonosetron was described as extremely stable at this pH.
Considering that the ’219 patent ultimately issued, the applicants were apparently successful in overcoming these obviousness rejections. In other words, the applicants convinced the examiner that a person of ordinary skill in the art would not have found it obvious to combine the teachings in the prior art to derived the claimed inventions.
The positions taken by the applicant, however, were utilized by the petitioner, Accord, to allege that a person of ordinary skill in the art would not have, for example, found the specification enabling. This highlights the problem that PGRs pose for patent applicants. Before such procedure, arguments could be made without much fear that they would be coopted by the Office for making alternative rejections. And, if the Office did, there would still an opportunity to provide a response or amend the claims. Even if such arguments were made in district court litigation, the patent would at least enjoy a presumption of validity.
Now, all applicants must take extreme caution in making any arguments, because anything said can (and probably will) be used against them at the PTAB.
Accord first alleged that the ’219 was unpatentable for failing to provide an adequate description of the claimed subject matter being stable at 18 or 24 months when stored at room temperature, as required by 35 U.S.C. § 112(a). Specifically, the petition asserted that the specification does not show that the inventors were in possession of any formulation that would have achieved the stability limitations of the claims.
Instead, the argument went, the patent contained general statements that it is possible to increase the stability of the formulations, but did not provide any examples with stability beyond a couple of weeks. Accord included a declaration from Dr. Arnold J. Repta, which explained how a person of ordinary skill in the art would have understood the teaching of the specification. However, Dr. Repta did not include any additional testing of the formulations taught in the application in his declaration.
The second assertion made in the petition was that the ’219 patent does not enable a pH range for the claimed formation outside of about 4.0 to 6.0, and therefore it is not enabled as required by 35 U.S.C. § 112(a). This is because, according the petition, the only relevant formulation in the specification was disclosed as having a pH of 5.0±0.5. Moreover, the specification was alleged to claim that palonosetron is most stable at pH 5.0.
Accord also cited to the Bonadeo Declaration, which was submitted during prosecution by the applicants, which alleged claimed that palonosetron formulations containing mannitol or EDTA required a pH of 4-6. Therefore, according to the petition, because the challenged claims do not recite any pH limitations, they were broader than the teaching of the specification.
“Regards as the Invention”
35 U.S.C § 112(b) requires that a patent “conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.” Accord challenged the claims of the ’219 patent as not including the invention as regarded by the inventors. Specifically, the petition alleges that the Bonadeo Declaration made clear that palonosetron was extremely stable at a pH of 5.0, and that there was no hint that a pH outside of the range of about 4.0 or 6.0 would be suitable. A similar argument was made about the language found in the specification. The petitioner concluded by pointing out that, even though the inventors believed that the inventive formation should be in a range of 4.0 to 6.0, such a limitation was not included in the claims.
Finally, Accord made a similar argument when alleging that the specification did not support claims that did not include a pH range of 4.0 to 6.0. Citing to the Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998), line of cases, the petitioner alleged that the pH range was an essential or critical feature which was omitted from that claims. In other words, Accord alleged that the broad claims without a pH limitation were invalid because the “entirety of the specification” demonstrates that the invention was of much narrower scope.
Of course, similar to an IPR, the patent owner now has a chance to submit a preliminary response to the petition. The standard used for instituting a PGR differs from that required for an IPR. Instead of the “reasonable likelihood” standard, a PGR will only be instituted when it is more likely than not that at least one of the claims challenged is unpatentable. In essence, this should be a slightly more stringent standard, because with both positions being equally likely, an IPR petition would have a reasonable likelihood of demonstrating claims as unpatentable, but a PGR petition would not be more likely than not to demonstrate unpatentable claims.
However, it remains to be seen if less PGRs are instituted than IPRs. We will continue to monitor PGR2014-00010, and provide updates as warranted.
35 U.S. Code § 112,