DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's amendment and remarks, filed 5/19/26, are acknowledged.
Claims 148, 150-155, 157-158, 160-163, 165-177 have been amended.
Claims 178-185 have been added.
Claims 148, 150-155, 157-158, 160-163, 165-185 are pending and are under examination.
In view of Applicant’s claims amendments and terminal disclaimer, only the following rejections remain.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 177 is 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:
a method for treating P. gingivalis infection in a subject in need thereof,
does not reasonably provide enablement for:
A method of treating a condition, disorder, or disease associated with a P. gingivalis infection..
The specification disclosure is insufficient to enable one skilled in the art to practice the invention as claimed without an undue amount of experimentation. Undue experimentation must be considered in light of factors including: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill in the art, the level of predictability of the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention, in re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
“The amount of guidance or direction needed to enable the 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 (MPEP 2164.03)” The MPEP further states that physiological activity can be considered inherently unpredictable.
The present claims are directed to a method of treating a condition, disorder, or disease associated with a P. gingivalis infection, comprising administering to the subject an antigen binding molecule that binds to P. Giginvalis. The claims encompass treating a wide range of different diseases and conditions with different etiologies and pathological mechanisms ranging from cancer, rheumatoid arthritis, cognitive disorders, any systemic disease, or vascular disease.
The state of the art is such that P. gingivalis infection can modulate the host’s immune response in a complex manner that may affect the cause of a large numbers of diseases, but more in-depth studies are required to understand the interactions between host and pathogen through disease development, and that current studies on P. gingivalis in affecting systemic disease are insufficient particularly on neurological disorders, respiratory disease, and kidney disease (see Li, 2022). See also Chung, 2022 which teaches that although P. gingivalis infection is associated with kidney disease, treatment of the infection does not change systemic outcomes in kidney disease. Thus, using a P. gingivitis antigen binding molecule to treat the wide range of disease encompassed by the present claims would be highly unpredictable.
Thus, based on the unpredictability of the art and the breadth of the claims, the instant specification must provide a sufficient and enabling disclosure commensurate in scope with the instant claims. However, no examples are provided for treating or any disease, and no guidance is provided regarding treating and preventing the genus of different disease and disorders encompassed by the present claims. Thus, based on the unpredictably of the art, the breadth of claims, and the lack of guidance provided in the instant specification, it would require undue experimentation to practice the method as broadly claimed.
Applicant’s arguments filed 5/19/26 have been fully considered, but they are not persuasive.
Applicant argues that the specification teaches that administration of the claimed antibody can reduce P. gingivalis infection and reduce inflammation, thereby treating the recited disease.
As noted above, the state of the art is such that P. gingivalis infection can modulate the host’s immune response in a complex manner that may affect the cause of a large numbers of diseases, but more in-depth studies are required to understand the interactions between host and pathogen through disease development, and that current studies on P. gingivalis in affecting systemic disease are insufficient particularly on neurological disorders, respiratory disease, and kidney disease (see Li, 2022). See also Chung, 2022 which teaches that although P. gingivalis infection is associated with kidney disease, treatment of the infection does not change systemic outcomes in kidney disease. In other words, treating P. gingivalis (i.e. reducing inflammation) in a patient with kidney disease does not treat the kidney disease, based on the teachings of the art. The present claims specifically encompass treating kidney disease. Likewise, the claims encompass any “systemic disease” or a genus of other diseases and given the unpredictably of the art, the lack of guidance or working examples in the instant specification, it would require undue experimentation to practice the full scope of the method of claim 177.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 148, 150-155, 157-158, 160-163, 165-185 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 19, 34 and 36 of copending Application No. 18/578,684. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘684 application claims a method of treating a gingipain-related disorder in a subject comprising administering to the subject an antigen binding molecule that binds to P. gingivalis wherein the antigen binding molecule comprises HDR1-3 from SEQ ID NO: 9 or 37 and LCDR1-3 from SEQ ID NO: 10 or 38, which are identical to SEQ ID NO: 9-10, and 37-38 of the instant application. The ‘684 application defines “antigen binding molecules” as referring to polypeptides that includes one or more fragments of an antibody, including, for example, a Fab or an immunoglobulin and also humanized antibodies. The ‘684 application discloses said antibody binding molecules comprising the same CDRs, VH, VL, and CH regions recited in the instant claims.. Thus, the claims in the ‘684 application cover the same antibodies and antibody fragments of the instant claims. The ‘684 application defines gingipain-related disorders include the same diseases recited in the instant claims, and thus the claims of the ‘684 application cover treating the same diseases. Furthermore, producing an antigen binding molecule by recombinant expression from a nucleic acid in a host cell is routine, obvious, and well within the purview of the ordinary artisan.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant argues that the double patenting rejection should be withdrawn since it is the only grounds of rejection remaining and the instant application has the earlier patent term fling date
The rejection is maintained since it is not the only rejection remaining. Once the other rejections are overcome, and the provisional nonstatutory double patenting rejections is the only rejection remaining, it will be withdrawn since the instant application has the earlier patent term filing date.
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 169 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 169 is indefinite since it depends from cancelled claim 159.
No claim is allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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