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 .
Claims 1 and 2 are pending and examined on the merits.
Claim Objections
Claim 2 is objected to because of the following informalities:
The recitation “the subject requires preventing, ameliorating or treating systemic sclerosis and pulmonary fibrosis” is not grammatically correct. The objection can be overcome by amending claim 2 to recite “the subject requires prevention, amelioration or treatment of systemic sclerosis and pulmonary fibrosis.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-2 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.
Claim 1 is rendered indefinite by the recitation “Bifidobacterium longum RAPO (KCTC13773BP).” It is unclear how the term in the parentheses modifies the term Bifidobacterium longum RAPO. Therefore, claims 1 and 2 are rejected under 35 U.S.C. 112(b). This rejection can be overcome by amending to claim 1 to recite “Bifidobacterium longum RAPO deposited under accession number KCTC13773BP.”
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 and 2 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 a method for ameliorating or treating systemic sclerosis, does not reasonably provide enablement for a method for preventing systemic sclerosis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? The claimed invention must be enabled so that any person skilled in the art can make and use the invention without undue experimentation.
Regarding undue experimentation, In re Wands, 8 USPQ2d 1400, at 1404 (Fed. Cir. 1988) states:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. (Citations omitted).
These factors are considered for determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue.” The claimed invention must be enabled so that any person skilled in the art can make and use the invention without undue experimentation.
The nature of the invention, prevention of systemic sclerosis, is complex as evidenced by Volkmann (The Lancet. 2023. 401(10373): 304-318. Published online November 25, 2022). According to Volkmann, systemic sclerosis, also known as scleroderma, is a rare and complex autoimmune connective-tissue disease (abstract). Also, Volkmann points out that the heterogeneous expression of systemic sclerosis poses challenges to both the patient and clinician, particularly with regard to predicting the development of serious internal organ involvement (page 304, left column). Moreover, clinicians often struggle to diagnose systemic sclerosis early in the disease course (page 304, left column). Therefore, at the time the claimed invention was made, it would have been challenging to determine the success of preventing systemic sclerosis by the administration of a composition comprising Bifidobacterium longum RAPO due to the rare prevalence of the disease and the difficulty in diagnosing systemic sclerosis. Moreover, due to the complexity of systemic sclerosis as demonstrated by its heterogenous expression, the prevention of systemic sclerosis is clearly a challenging endeavor. Volkmann also is indicative of the state of the prior art, which is the absence of any promising method of preventing systemic sclerosis. Volkmann recognizes that systemic sclerosis was “Once considered an untreatable and unpredictable condition,” and research advancements for improving scientists’ understanding of its disease pathogenesis and clinical phenotypes were still being developed as of the 2022 publication date of Volkmann (abstract). Therefore, at the time the claimed invention was made, there had yet been successful prediction and diagnosis of systemic sclerosis that would be necessary in order to ascertain successful prevention of systemic sclerosis.
Furthermore, the quantity of experimentation required for determining whether the claimed method is effective for preventing systemic sclerosis is tremendous. This is because of the heterogeneous nature of the disease. Also, the subject sample size for a study to determine the effectiveness of the treatment for preventing systemic sclerosis would be large because the disease is rare. Therefore, a study for determining the effectiveness of the claimed invention for preventing systemic sclerosis would be expected to be lengthy due to the large number of subjects that need to be tested over their lifetime.
Additionally, the specification as filed fails to provide any working example demonstrating the prevention of systemic sclerosis by administering to a subject a composition comprising Bifidobacterium longum RAPO (deposited under accession number KCTC13773BP) as an active ingredient. Instead, the specification describes the antifibrotic efficacy of the RAPO strain in mice with systemic sclerosis (Figures 1 and 2; Example 1 on pages 15-21 of the specification) and the strain’s anti-inflammatory and antifibrotic efficacy (Experimental Example 4 on pages 31-36 of the specification), which are directed to ameliorating or treating systemic sclerosis.
Given the nature of the invention, the state of the prior art, the quantity of experimentation necessary, and the absence of any working example, then undue experimentation would be required to perform the full scope of the claimed invention. Accordingly, claims 1 and 2 are rejected under 35 U.S.C. 112(a).
Notice Re: Prior Art Available Under Pre-AIA and AIA
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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (Annals of the Rhematic Diseases. EULAR European Congress of Rheumatology, EULAR 2023. May 31-June 3, 2023. Oral Presentations. POS0622. Pages 584-585. Listed on IDS filed 1/31/25) or Kim (Lupus & KCR 2023 Program Book. The 15th International Congress on Systemic Lupus Erythematosus and the 43rd KCR Annual Scientific Meeting & 17th International Symposium. May 17-20, 2023. E-Poster Presentation KP-069. Page 394. Listed on IDS filed 1/31/25).
Lee and Kim each discloses a study screening systemic sclerosis (SSc)-associated microbiome at the species level using serum and exploring potential microbial targets for SSc treatment (Objectives section of Lee; Background section of Kim). In particular, the antifibrotic effect of candidate microbial species was investigated using a bleomycin (BLM)-induced fibrosis model in mice (Methods section of both Lee and Kim). Lee and Kim both determined that Bifidobacterium longum RAPO alleviated BLM-induced skin and lung fibrosis in mice (Results section of Lee and Kim). It was concluded that B. longum RAPO could have an antifibrotic effect on skin and lung fibrosis in BLM-induced fibrosis mice, and that microbial intervention would be a potential option for SSc treatment (Conclusion(s) section of Lee and Kim). The titles of Lee and Kim refer to the BLM-induced fibrosis in the mice as “bleomycin-induced systemic sclerosis.” Therefore, in alleviating BLM-induced skin and lung fibrosis in mice, Lee and Kim each discloses a method for ameliorating or treating systemic sclerosis, the method comprising administering to a subject in need thereof a composition comprising B. longum RAPO (deposited under accession number KCTC1377BP) as an active ingredient, anticipating instant claim 1.
Since the mice have lung fibrosis that is BLM-induced (bleomycin-induced systemic sclerosis as in the titles), then Lee and Kim each discloses that the subject (a mouse) requires the amelioration or treatment of systemic sclerosis and pulmonary fibrosis, anticipating instant claim 2.
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.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Moon (WO 2022/108392. Machine Translation cited below) in view of Ji (US 2021/0154244), as evidenced by Volkmann (The Lancet. 2023. 401(10373): 304-318. Published online November 25, 2022).
Moon discloses a method of treating scleroderma comprising administering Bifidobacterium to an individual having a reduced number of Bifidobacterium compared to a control group (page 10, last paragraph). As evidenced by Volkmann, scleroderma is also known as systemic sclerosis (abstract). The Bifidobacterium can be Bifidobacterium longum (fourth paragraph on page 16), and Example 2 of Moon teaches obtaining a fibrosis inhibitory effect by administration of Bifidobacterium longum in an animal model of scleroderma (Example 2 on pages 12-13). Therefore, Moon meets limitations of the claimed invention by disclosing a method for ameliorating or treating systemic sclerosis (i.e., scleroderma), the method comprising administering to a subject in need thereof a composition comprising Bifidobacterium longum as an active ingredient.
Moon differs from the claimed invention in that Moon does not expressly disclose that the Bifidobacterium longum is B. longum RAPO deposited under accession number KCTC13773BP.
Ji discloses Bifidobacterium longum RAPO having an Accession No. KCTC 13773BP (paragraph [0041]). The RAPO strain has an excellent effect of inhibiting IL-17 (paragraph [0042]). Also, Ji discloses that the RAPO strain has better immunomodulatory capability than other bacteria (paragraph [0042]).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to substitute the Bifidobacterium longum of the method of Moon with Bifidobacterium longum RAPO for the predictable result of treating systemic sclerosis (i.e., scleroderma). It would have been an obvious matter of simple substitution of Bifidobacterium longum for another. Moreover, one of ordinary skill in the art would have been motivated to select the RAPO strain as the Bifidobacterium longum for practicing the method of Moon because the RAPO strain has an excellent effect of inhibiting IL-17 which would have been sought by Moon since Moon teaches an inhibitory effect on IL-17 by administration of Bifidobacterium longum in an animal model of scleroderma (Example 4 on page 13), and because the RAPO strain has better immunomodulatory capability than other bacteria which would have been sought by Moon since Moon recognizes that conventional immunosuppressive agents have been used for the treatment of scleroderma (page 14, first paragraph). There would have been a reasonable expectation of treating systemic sclerosis by administration of the RAPO strain because Moon teaches administration of Bifidobacterium in general, including Bifidobacterium longum in general for the effect of treating systemic sclerosis. Therefore, instant claim 1 is rendered obvious.
Regarding instant claim 2, in treating systemic sclerosis by the method rendered obvious by Moon in view of Ji, then the subject being treated requires the amelioration or treatment of systemic sclerosis. As evidenced by Volkmann, 50-65% of patients with systemic sclerosis will exhibit interstitial lung abnormalities on high-resolution computed tomography (HRCT) (page 307, left column, second full paragraph). Moreover, these lung abnormalities include pulmonary fibrosis (page 307, paragraph bridging left and right columns). Therefore, in treating systemic sclerosis in a subject when practicing the invention rendered obvious by Moon in view of Ji, it would have been obvious that the subject also requires the prevention, amelioration, or treatment of pulmonary fibrosis since it is known to be exhibited by patients with systemic sclerosis. Therefore, instant claim 2 is rendered obvious.
Double Patenting
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 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10, 15, and 16 of copending Application No. 18/036,771 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `771 comprising administering a composition comprising Bifidobacterium longum RAPO having accession no. KCTC13773BP to a subject. The subject of the claims of `771 is a subject in need of breast cancer treatment. Since the prevention of systemic sclerosis is necessitated in all people, the instant claims encompass administering the composition comprising the RAPO strain as an active ingredient to any and all patient populations. Therefore, the patient population of the claims of `771 (subjects in need of breast cancer treatment) falls within the scope of the instantly claimed embodiment of a method of preventing systemic sclerosis. In administering a composition comprising the RAPO strain to a subject, then the claims of `771 necessarily result in the claimed effect of preventing systemic sclerosis. Therefore, the claims of `771 render obvious instant claim 1. Any subject, including a subject in need of breast cancer treatment as in the claims of `771, is a subject that requires prevention of systemic sclerosis and pulmonary fibrosis. Therefore, the claims of `771 render obvious instant claim 2.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,135,254.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `254 recite a food composition (claims 1 and 2 of `254) or a pharmaceutical composition (claim 3 of `254) comprising Bifidobacterium longum RAPO (Accession no. KCTC13773BP). A food composition and a pharmaceutical composition are necessarily administered to a subject, so the claims of `254 set forth administering to a subject a composition comprising the RAPO strain as an active ingredient. The subject of the claims of `254 is a subject in need of the alleviation of rheumatoid arthritis (claims 1 and 2 of `254) or a subject in need of the prevention or treatment of rheumatoid arthritis (claim 3 of `254). Since the prevention of systemic sclerosis is necessitated in all people, the instant claims encompass administering the composition comprising the RAPO strain as an active ingredient to any and all patient populations. Therefore, the patient population of the claims of `254 (subjects in need of the alleviation of rheumatoid arthritis; subjects in need of the prevention or treatment of rheumatoid arthritis) falls within the scope of the instantly claimed embodiment of a method of preventing systemic sclerosis. In administering a food or pharmaceutical composition comprising the RAPO strain to a subject, then the claims of `254 necessarily result in the claimed effect of preventing systemic sclerosis. Therefore, the claims of `254 render obvious instant claim 1. Any subject, including a subject in need of the alleviation of rheumatoid arthritis or in need of the prevention or treatment of rheumatoid arthritis, in the claims of `254, is a subject that requires prevention of systemic sclerosis and pulmonary fibrosis. Therefore, the claims of `254 render obvious instant claim 2.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN EMILY FERNANDEZ whose telephone number is (571)272-3444. The examiner can normally be reached 10:30am - 7pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Sef
/SUSAN E. FERNANDEZ/ Examiner, Art Unit 1651
Prosecution Insights