DETAILED 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 .
Claims 1-17 remain pending and examined on the merits as drawn to the elected species and inventive concept (see previous Interview Summary).
9/25//25 Interview Summary: An interview was held with applicant’s representative, the summary of which is provided the rejection below, necessitated by argument(s)/amendment(s).
Election/Restrictions - Maintained
Applicant’s election without traverse of the species below in the reply filed on is acknowledged:
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The latter was found free of the prior art of record per the original STN search. Beyond said elected species, as to any amylin analogue, claims 1-17 are searched and examined as drawn to the elected species combination of amylin analogue pramlinitide in combination with ZnCl2 and Nacl in solution for improving amylin stability at neutral pH; see per Example C6 and specification para [0746]:
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Claim Rejections - 35 USC § 112(b) - Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(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.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements and/or steps and/or the structural cooperation of either or both as to critical/essential elements of the intended invention scope, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are as summarized in the attached interview relevant to an identifier labeled B1:
Following a thorough review and discussion of the arguments (page 1, relevant to B1 as potentially critical/essential yet not reflected as such in the current claim scope) in view the current claims scope, applicant's representative (AR) requested that an Office action setting for the issue so that he and applicant may weigh possible claim amendments to address such. Namely, early in the arguments first actual page, actual on page 20, applicant refers to and argues “. . . a co-polyamino acid (B1) is used to stabilize pramlintide at a neutral pH, because pramlintide is not stable without it.” The examiner reached out to applicant to guide him as to where this B1 identifier was set forth in the claims, if required as argued to stabilize pramliniide, unless the examiner was overlooking such. AR did not immediately find such set forth in the claim scope either, but offered hat B1 is 'described' (even if not claimed) in the specification beginning at specification paragraph 637. The examiner relayed that it would appear B1 is critical/essential to the inventive concept per para 637 and the arguments thereto and that if so, the claim needs to reflect this and be incorporation therein to positively recite all required (critical/essential) elements. The examiner stated that at a minimum the arguments raised new issues as to metes and bounds of the intended invention scope tied to the structural cooperation of the elements as indefinite, and that in order for a reasonable search of the intended invention scope to be carried out, the arguments and claim scope would need to align. While no final agreement was reached as to any proposed amendments to achieve this, AR indicated this will be fully addressed with applicant and a response thereafter.
As such the opening argument as to identifier B1 and discussion held thereof renders at a minimum the metes and bounds of the intended claim scope indefinite until further amendment and/or arguments. A reasonable updated search of the ‘intended’ claim scope is not possible until such is resolved.
Claim Rejections - 35 USC § 103 - Maintained;
Disposition Held In Abeyance Until New 112(b) Issued Addressed Above;
As to Critical/Essential Elements Being Claimed Aligned w/ Arguments
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-17, as drawn to the elected species combination of amylin analogue pramlinitide in combination with ZnCl2 and Nacl in solution for improving amylin stability at neutral pH; see per Example C6 and specification para [0746]:
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remain rejected under 35 U.S.C. 103 as being unpatentable over Arecor Limited (WO2018060736).
Arecor teach (see sections below, even if not the originally elected product species, see original election) the genus of solutions comprising amylin (including the selection of pramlinitide, claim 70) in solution with the combination of ZnCl2 and NaCl; and render obvious the routinely optimizable concentrations thereof, even if not expressly at those set forth in instant Example C6 (the elected inventive concept).
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The Issue: Whether it would have been prima facie obvious to combine ZnCl2 and NaCl to improve the stability of amylin analogue pramlinitide, especially by increasing the amount of ZnCl2 thereof to improve stability even greater?
Based on the teachings and suggestions of Arecor, the instantly elected genus is rendered prima facie obvious to arrive at, absent amendment of the claims commensurate in scope with evidence of increasing amounts of ZnCl2 alongside a ratio with NaCl that yield secondary considerations of unexpected results as to stability of pramlitide/amylin solutions therewith.
Claim Rejections - 35 USC § 112(a)(i)/(pre-AIA )-Written Description,
Scope, Inventive Concept Tied to Elected Species;
Maintained, Disposition Held In Abeyance Until New 112(b) Issued Addressed Above;
As to Critical/Essential Elements Being Claimed Aligned w/ Arguments
The following is a quotation 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.
Claims 1-17 remain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing/identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functionalcharacteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
In this case, applicant has shown possession of certain combinations of elements capable of improving stability of amylin compositions (e.g. analogue pramlinitide), as to the elected combination of ZnCl2 and NaCl and concentrations thereof versus standard means:
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In the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description (possession) that the inventive concept of improved stability over other standard means can be achieved with just any combination of elements and concentrations thereof; but rather only certain combinations and concentrations thereof, per the test data of record.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111; clearly states that "applicant 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." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Therefore, the full breadth of the claims as drawn to the elected species combination/concentrations thereof are not presently deemed to have been in Applicant’s ‘possession’ and found to meet the written description provision of 35 U.S.C. §112.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MAURY A AUDET/Primary Examiner, Art Unit 1654