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 1-20 have an effective filing date of 05 MAY2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/11/2024 and 6/22/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of Claims
Claims 1-20 are currently pending and presented for examination on the merits.
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 1-12 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 method of treating or preventing a headache disorder in a subject in need thereof. However, the written description in this case only sets forth treating headache in KO CCR2 mice and CCR2 antagonist RS504393 in the Examples in the Specifications. The specification does not disclose, and the art does not teach, the genus of a method of preventing and/or treating a headache disorder in a subject in need thereof as broadly encompassed in the claims.
The specification discloses the treating a headache, but does not teach a method of preventing and/or treating a headache disorder in a subject in need thereof. The written description only reasonably conveys treating headache in the specifications by gene KO and RS504393. 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.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features 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 methods of preventing and/or treating a headache disorder in a subject in need thereof that encompass the genus of a method of preventing and/or treating a headache disorder in a subject in need thereof 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).
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a headache disorder, such as migraine, by administering the claimed therapeutic agents, does not reasonably provide enablement for preventing a headache disorder, such as a migraine, by administering the claimed therapeutic agents. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term “undue experimentation,” it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include but are not limited to:
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The breadth of the claims;
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The nature of the invention;
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The state of the prior art;
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The level of one of ordinary skill;
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The level of predictability in the art;
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The amount of direction provided by the inventor;
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The existence of working examples; and
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The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The factors most relevant to this rejection are 1) the amount of direction provided by the inventor and 2) the existence of working examples. In the instant case, the amount of direction provided by the inventor and existence of working examples disclosed in the specification, as filed, would not be sufficient to enable the skilled artisan to make and/or use the claimed invention at the time the application was filed without undue experimentation.
(1) The amount of direction provided by the inventor - The amount of guidance or direction needed to enable an invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004). Due to the high level of unpredictability and the general lack of understanding associated with headache prevention, the skilled artisan would need significant guidance in preparing a composition that may be used to prevent headaches. The skilled artisan recognizes that preventing cancer is an intractable proposition, if not now wholly impossible, given, for example, that cancers are widely heterogeneous diseases, having widely varying pathologies and etiologies, and with causes that are multifactorial and as yet only partially characterized and poorly understood. It is generally recognized that a disease cannot be prevented unless and until its causes are fully appreciated and understood to a degree that it becomes possible to intercede effectively to block its onset or development by any cause.
(2) The existence of working examples - As stated above the specification reasonably provides enablement for treating headaches by administering the claimed therapeutic agents; however there is no showing in the specification of any means by which one skilled in the art could use the claimed therapeutic agents to prevent headaches. Therefore one skilled in the art would be subject to undue experimentation to practice the instant invention as it is currently claimed.
In conclusion upon careful consideration of the Wands factors that are used to determine whether undue experimentation is required to practice an invention, the amount of direction provided by the inventor and the working examples provided, as filed, is not deemed sufficient to enable the skilled artisan to make and/or use the invention commensurate in scope with the instant claims at the time the application was filed without undue experimentation.
Claims 1-6, 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 chemokine CC motif ligand 2 (CCL2)-CC chemokine receptor type 2 (CCR2) signaling inhibiting agent; however, the written description in this case only sets forth the CCL-CCR2 inhibiting agent RS504393. The specification does not disclose, and the art does not teach, the genus of a chemokine CC motif ligand 2 (CCL2)-CC chemokine receptor type 2 (CCR2) signaling inhibiting agent as broadly encompassed in the claims.
The specification discloses RS504393, but does not teach a genus of a chemokine CC motif ligand 2 (CCL2)-CC chemokine receptor type 2 (CCR2) signaling inhibiting agent. 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 chemokine CC motif ligand 2 (CCL2)-CC chemokine receptor type 2 (CCR2) signaling inhibiting agents, 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).
Claims 8 and 19 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).
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, 6-15, and 17-20 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, 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].
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 claims 6-7, Solis-Castro et al teaches attenuating the effects by injections of CCR2 antagonist RS504393 [Left column, 2nd Paragraph, pg. 7].
In regards to claim 9, a CCL2-CCR2 signaling inhibiting agent is administered at a sub-effective dose, the amount of the antibody in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention.
The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."(Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claims 10 and 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 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 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].
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 claims 17-18, Solis-Castro et al teaches attenuating the effects by injections of CCR2 antagonist RS504393 [Left column, 2nd Paragraph, pg. 7].
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].
Solis-Castro et al does not specifically teach CGRP inhibiting agents. However, this deficiency is made up in the teachings of Scheffler et al.
In regards to claims 8, 11, and 19, Scheffler et al teaches the use of CGRP antibodies for treating migraines [Abstract].
One of ordinary skill in the art, before the effective filing date, would have been motivated to combine Solis-Garcia’s method of treating migraine headaches by administering CCR2 antagonist RS504393, with Scheffler’s method of treating migraine headaches with CGRP antibody. 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 and Scheffler’s methods for a method of treating a headache disorder by administering a CCR2 and CGRP antibodies because both Solis-Garcia and Scheffler teach this as a treatment for migraine headaches.
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, 6-15, and 17-20, 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.
Conclusion
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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/DENNIS J SULLIVAN/ Examiner, Art Unit 1642
/NELSON B MOSELEY II/ Primary Examiner, Art Unit 1642