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
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-5, 11-16, and 20 have an effective filing date of 04MAY2022.
Status of Claims
Claims 1-5, 11-16, and 20 are currently pending and presented for examination on the merits.
Claims 1, 4-5, 11-13, 15-16, and 20 are amended.
Claims 6-10, and 17-19 are canceled.
Rejections Withdrawn
The rejections filed for claims 1-12 under 35 U.S.C. 112(a) Written Description is withdrawn in view of Applicant’s amendments to claims.
The rejection filed for claims 1-12 under 35 U.S.C. 112(a) Enablement is withdrawn in view of Applicant’s amendments to claims.
The rejection filed for claims 1-6, 8-17, 19, and 20 under 35 U.S.C. 112(a) Written Description is withdrawn in view of Applicant’s amendments to claims.
The rejection filed for claims 8 and 19 under 35 U.S.C. 112(a) Written Description is withdrawn in view of Applicant canceling the claims.
Rejections Maintained
Claim Rejections - 35 USC § 103
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.
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 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.
Claims 1-4, 11-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Solis-Castro et al (Chemokines and Pain in the Trigeminal System, Frontiers in Pain, Vol. 2, Article 689314, 2021, IDS 6/11/2024), and further in view of Scheffler et al (CGRP antibody therapy in patients with drug resistant migraine and chronic daily headache: a real-world experience, Journal of Headache and Pain, 22:111, pgs. 1-6, 2021).
In regards to claims 1-3, and 13, Solis-Castro et al teach the levels of chemokines in human samples associated with migraine [Search Summary, pg. 2]. Solis-Castro et al further teaches patients with migraine (commonly associated with mild traumatic brain injury) or tension-type headache contained significantly higher levels of CCL2 in comparison with healthy controls [Chemokine Presence In Human Cases of Trigeminal Pain, 1st paragraph, pg. 11]. Solis-Castro further teaches the role of CCL2 and CCR2 in neuropathic, mechanical and inflammatory-induced pain at the different levels of the trigeminal system [Left column, 2nd Paragraph, pg. 6]. Solis-Castro et al further teaches CCL2 gene expression in the injured tissue contributes to inflammatory pain [Right column, 2nd Paragraph, pg. 11]. Solis-Castro et al further teaches attenuating the effects by injections of CCR2 antagonist RS504393 [Left column, 2nd Paragraph, pg. 7]. Solis-Castro et al teaches attenuating the effects by injections of CCR2 antagonist RS504393 [Left column, 2nd Paragraph, pg. 7].
Solis-Castro et al does not specifically teach CGRP inhibiting agents. However, this deficiency is made up in the teachings of Scheffler et al.
Scheffler et al teaches the use of CGRP antibodies for treating migraines [Abstract].
One of ordinary skill, before the effective filing date, would have been motivated to combine Solis-Castro’s method of treating a headache comprising administering the CCR2 agonist RS504393, with Scheffler’s method of treating a headache comprising a CGRP inhibiting agent. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Solis-Castro and Scheffler’s methods for a method of treating a headache comprising administering CCR2 antagonist RS504393 and a CGRP inhibiting agent, because combining prior art elements according to known methods to yield predictable results supports a conclusion of obviousness.
In regards to claim 4, Solis-Castro et al teaches a neutralizing antibody directed against CCL2 [Left column, 3rd Paragraph, pg. 5].
In regards to claim 11, Scheffler et al teaches the CGRP antibodies erenumab, fremanezumab, and galcanezumab [Abstract].
In regards to claim 12, Solis-Castro et al teaches CCR2 inhibition with INCB3344 was shown to prevent mechanical hypersensitivity [Right column, 1st Paragraph, pg. 6].
In regards to claim 14, Solis-Castro et al teach the levels of chemokines in human samples associated with migraine [Search Summary, pg. 2].
In regards to claim 15, Solis-Castro et al teaches a neutralizing antibody directed against CCL2 [Left column, 3rd Paragraph, pg. 5].
In regards to claim 20, Solis-Castro et al teaches CCR2 inhibition with INCB3344 was shown to prevent mechanical hypersensitivity [Right column, 1st Paragraph, pg. 6].
Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Solis-Castro et al (Chemokines and Pain in the Trigeminal System, Frontiers in Pain, Vol. 2, Article 689314, 2021, IDS 6/11/2024), and further in view of Scheffler et al (CGRP antibody therapy in patients with drug resistant migraine and chronic daily headache: a real-world experience, Journal of Headache and Pain, 22:111, pgs. 1-6, 2021), as applied to claims 1-4, 11-15, and 20, and further in view of Benschop et al. (WO 2017/074428, publication date: 05/04/2017).
As indicated above one of ordinary skill, before the effective filing date, would have been motivated to combine Solis-Garcia’s method of treating migraine headaches by administering a CCR2 antagonist antibody with Scheffler’s method of treating migraine headaches with a CGRP antibody.
Benschop et al teach bispecific antibodies that bind to CGRP and an additional antigen [page 1, first paragraph].
One of ordinary skill in the art, before the effective filing date, would have been motivated to combine Solis-Garcia’s and Scheffler’s method of treating migraine headaches by administering a neutralizing antibody directed against CCR2 and an CGRP antibody with the bispecific antibody of Benschop et al to develop a method of treating migraine headaches by administering a bispecific antibody directed against CCR2 and CGRP. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Solis-Garcia’s and Scheffler’s methods with the bispecific antibody of Benschop et al to arrive at a method of treating a migraine headache by administering a bispecific antibody directed against CCR2 and CGRP. One of ordinary skill in the art would further appreciate that a bispecific antibody directed against CCR2 and CGRP provides a convenient means of administering both an anti-CCR2 antibody and an anti-CGRP antibody.
Applicant’s Arguments:
…claims 1 and 13 are amended herein to require administration of a combination treatment comprising a CGRP inhibiting agent as well as a CCL2-CCR2 signaling inhibiting agent comprising RS504393. Consequently, the subject matter of independent claims 1 and 13, and the claims dependent thereon, is neither taught nor suggested by the reference combination of Solis-Castro+Scheffler, with or without further combination with Benschop.
Examiner’s Response:
Solis-Castro et al teach the levels of chemokines in human samples associated with migraine [Search Summary, pg. 2]. Solis-Castro et al further teaches patients with migraine (commonly associated with mild traumatic brain injury) or tension-type headache contained significantly higher levels of CCL2 in comparison with healthy controls [Chemokine Presence In Human Cases of Trigeminal Pain, 1st paragraph, pg. 11]. Solis-Castro further teaches the role of CCL2 and CCR2 in neuropathic, mechanical and inflammatory-induced pain at the different levels of the trigeminal system [Left column, 2nd Paragraph, pg. 6]. Solis-Castro et al further teaches CCL2 gene expression in the injured tissue contributes to inflammatory pain [Right column, 2nd Paragraph, pg. 11]. Solis-Castro et al further teaches attenuating the effects by injections of CCR2 antagonist RS504393 [Left column, 2nd Paragraph, pg. 7]. Solis-Castro et al teaches attenuating the effects by injections of CCR2 antagonist RS504393 [Left column, 2nd Paragraph, pg. 7].
Solis-Castro et al does not specifically teach CGRP inhibiting agents. However, this deficiency is made up in the teachings of Scheffler et al.
Scheffler et al teaches the use of CGRP antibodies for treating migraines [Abstract].
One of ordinary skill, before the effective filing date, would have been motivated to combine Solis-Castro’s method of treating a headache comprising administering the CCR2 agonist RS504393, with Scheffler’s method of treating a headache comprising a CGRP inhibiting agent. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Solis-Castro and Scheffler’s methods for a method of treating a headache comprising administering CCR2 antagonist RS504393 and a CGRP inhibiting agent, because combining prior art elements according to known methods to yield predictable results supports a conclusion of obviousness.
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.
Claims 1-5, 12-16, and 20 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.
In the instant case, the claims are inclusive of a genus of a CGRP inhibiting agent; however, the written description in this case only sets forth that a CGRP inhibiting agent can be ALD405, Erenumab (Aimovig), Fremanezumab (Ajovy), Galcanezumab (Emgality), or Eptinezumab (Vyepti), but does not teach a genus of a CGRP inhibiting agents. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or by describing structural features common to that genus that “constitute a substantial portion of the genus.”
The instant specification fails to provide sufficient descriptive information, such as definitive structural features that are common to the genus. That is, the specification provides neither a representative number of species of a genus of a CGRP inhibiting agent that encompass the genus of a genus of a CGRP inhibiting agent nor does it provide a description of structural features that are common to the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus. “[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a “representative number” of species. Since the disclosure fails to describe common attributes or characteristics that adequately identify members of the genus, and because the genus is highly variant, the disclosure of methods of preventing and/or treating cancer in a subject in need thereof is insufficient to describe the genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “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). As discussed above, even though Applicant may propose methods of screening for possible members of the genus, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolation. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. See Ariad, 94 USPQ2d at 1161; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Applicant’s Arguments:
Without commenting on the rejections, and in the interest of advancing meaningful prosecution, claims 1, 4, 5, 11-13, 15, 16, and 20 are amended as shown above for purposes of clarification.
Examiner’s Response:
In the instant case, the claims are inclusive of a genus of a CGRP inhibiting agent; however, the written description in this case only sets forth that a CGRP inhibiting agent can be ALD405, Erenumab (Aimovig), Fremanezumab (Ajovy), Galcanezumab (Emgality), or Eptinezumab (Vyepti), but does not teach a genus of a CGRP inhibiting agents.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is 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.
Claim 11 contains the trademark/trade names Aimovig, Ajovy, Emgality, and Vyepti. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe erenumab, fremanezumab, galcanezumab, and eptinezumab and, accordingly, the identification/description is indefinite.
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 DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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