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 . The amendment filed on 06/25/2026 has been entered. Claims 1-70, 78, and 79 are cancelled. Claims 86-92 are new and claims 71-77 and 80-92 are pending in this application. Claims 86-92 are withdrawn. Claims 71-77 and 80-85 are pending in this application, and are currently under examination.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Claims 71-77 and 80-85, drawn to method of reducing the probability of or ameliorating age-related macular degeneration (AMD) in a subject in need thereof, the method comprising administering to the subject an effective amount of an antibiotic or a pharmaceutically acceptable salt thereof, wherein the subject is not administered an anti-VEGF medication (claim 71), classified in classes/subclasses, including but not limited to, C12N1/20 (Bacteria; Culture media therefor).
Claims 86-89, drawn to A method of reducing drusenoid lesion or drusen-like nodules in a subject in need thereof, the method comprising administering to the subject an effective amount of an antibiotic or a pharmaceutically acceptable salt thereof (claim 86), classified in classes/subclasses, including but not limited to, A01K2267/03 (Animal model, e.g. for test or diseases).
III. Claims 90-92, drawn to A method of (i) reducing pyroptosis of the retinal pigment epithelium cells in the eye; (ii) reducing activation of the complement system and/or inflammation in the eye; or (iii) reducing secretion of active IL-1~ and/or IL-18 by retinal pigment epithelium cells in the eye, of a subject in need thereof, the method comprising administering to the subject an effective amount of an antibiotic or a pharmaceutically acceptable salt thereof (claim 90), classified in classes/subclasses, including but not limited to, G01N33/5044 (involving specific cell types).
Inventions I/II, I/III, or II/III are unrelated. Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06). In the instant case, Invention I is directed to a method targeting a subject having age-related macular degeneration (AMD) or pre-AMD lesions, whereas Invention II is directed to a method targeting a subject having drusenoid lesion or drusen-like nodules, inducible in animal model and may or may not associate with AMD, and Invention III is directed to a method targeting a subject having (i) pyroptosis of the retinal pigment epithelium cells; (ii) activation of the complement system and/or inflammation; or (iii) secretion of active IL-1ß and/or IL-18 by retinal pigment epithelium cells, in the eye, which may or may not associate with AMD, drusenoid lesion, or drusen-like nodules. Thus, they are not disclosed as capable of use together and they have different designs and modes of operation.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classification.
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Since claims 71-77 and 80-85 have been examined but have not yet allowed, the new claims 86-92 having distinct inventios are not examined here.
Priority
This application is a DIV of 17/293,991 filed on 05/14/2021, now PAT 12016312, which is a 371 of PCT/CN2019/117444 filed on 11/12/2019 and claims foreign priority of PCTCN2018118929 filed on 12/03/2018 and CHINA 201811351660.9 filed on 11/14/2018.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/293,991, filed on 05/14/2021.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application (CHINA 201811351660.9) must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
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. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. CHINA 201811351660.9, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 71-77 and 80-85 recite “reducing the probability of or ameliorating age-related macular degeneration (AMD) in a subject in need thereof… administering to the subject an effective amount of an antibiotic or a pharmaceutically acceptable salt thereof (or selected from the group consisting of Amikacin, Amoxicillin, Ampicillin, Arsphenamine… Teixobactin, Malacidins, and combinations thereof; or selected from the group consisting of ciprofloxacin, ceftazidime, ampicillin, chloramphenicol, and vancomycin)”, “the subject is infected with, in the intraocular space, one or more microorganism species selected from the group consisting of Staphylococcus epidermidis, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus haemolyticus, Pseudomonas putida, Stenotrophomonas maltophilia, Bacillus cereus, Bacillus megaterium, Lactobacillus reuteri, Gardnerella vaginalis, Enterococcus faecium, Cytophaga hutchinsonii, Bacillus licheniformis, and Xanthomonas oryzae (or Bacillus megaterium; or the antibiotic or pharmaceutically acceptable salt thereof… in an amount effective in killing or inhibiting the growth of the one or more microorganism species in the eye, blood, and/or GI tract), and/or “the pharmaceutical composition is administered orally (or topically, intravitreously, intramuscularly, subcutaneously, or intravenously)”, which are not disclosed or supported by the prior-filed Application No. CHINA 201811351660.9. Thus, the priority of claims 71-77 and 80-85 is 12/03/2018.
Withdrawn Claim Objections/Rejections
The objection of claims 72-74, 77, 79, and 84 because of improper recitations, as set forth on page 4 of the Non-Final Rejection mailed on 03/25/2026, is withdrawn in view of amended claims 72-74, 77, and 84, and cancelled claim 79.
The rejection of claims 71-85 under 35 U.S.C. 112(a), as set forth on pages 5-8 of the Non-Final Rejection mailed on 03/25/2026, is withdrawn in view of amended claim 71, and cancelled claims 78 and 79. Claims 72-77 and 80-85 depend from claim 71.
The rejection of claims 75 and 77 under 35 U.S.C. 112(b), as set forth on page 9 of the Non-Final Rejection mailed on 03/25/2026, is withdrawn in view of amended claims 75 and 77.
The rejection of claims 71-78 and 80-85 under 35 U.S.C. 103 as being unpatentable over Klein in view of Wen et al. and Greenway et al., as set forth on pages 12 to 13 of the Non-Final Rejection mailed on 03/25/2026, is withdrawn in view of cancelled claim 78, depending from rejected claim 71 under 102.
The rejection of claims 71-77 and 79-85 under 35 U.S.C. 103 as being unpatentable over Klein et al. in view of Wen et al. and Chao et al., as set forth on pages 13-15 of the Non-Final Rejection mailed on 03/25/2026, is withdrawn in view of cancelled claim 79, depending from rejected claim 71 under 102.
The provisional rejection of claims 71, 74-77, and 80-85 on the ground of nonstatutory double patenting as being unpatentable over claims 57, 59, and 61 of copending Application No. 17/293,603, as set forth on page 17 of the Non-Final Rejection mailed on 03/25/2026, is withdrawn in view of amended claims in the copending Application No. 17/293,603.
New (necessitated by amendment) 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 71-77 and 80-85 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amended claim 71 recites "the subject is not administered an anti-VEGF medication”, which is not disclosed or supported by the originally filed application. “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981)”. See MPEP § 2163.06 [R-01.2024][I].
To advance prosecution, the new matter is examined with the effective filing date of 06/25/2026 as filed. Claims 72-77 and 80-85 depend from claim 71.
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 71-74, 76, and 80-85 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klein et al. (Ophthalmology Volume 116, Number 6, June 2009, p. 1225-1225e1, hereinafter referred to as Klein ‘2009) as evidenced by Wen et al. (Progress in Retinal and Eye Research 64:84–95, 2018, Available online 19 January 2018, hereinafter referred to as Wen ‘2018, also listed in IDS filed on 05/06/2024).
With regard to structural limitations “a method comprising administering (or orally; or intravitreously) to a subject suffering from age-related macular degeneration (AMD or a wet age-related macular degeneration with a hard or soft drusen symptom; or the subject is also infected with Staphylococcus epidermidis in the intraocular space) an effective amount of an antibiotic (or ciprofloxacin, ceftazidime, vancomycin, or moxifloxacin), wherein the subject is not administered an anti-VEGF medication (claim interpretation: the anti-VEGF medication is not administered along with the antibiotic)” (claims 71-74 and 80-85):
Klein ‘2009 disclosed that intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents have become the standard of care for the treatment of neovascular age-related macular degeneration. Endophthalmitis is the most dreaded complication of intravitreal injection. A total of 15 cases of presumed endophthalmitis is identified from a cohort of 30,736 injections. Fourteen of 15 endophthalmitis patients were tapped and injected intravitreally with vancomycin and ceftazidime. One of the 15 patients was tapped then injected intravitreally with vancomycin only. One patient was placed on oral ciprofloxacin, and 2 were placed on oral moxifloxacin. Six of 13 (46%) cases were culture positive. Only gram positive organisms were isolated: Staphylococcus epidermidis x 3, coagulase-negative staphylococcus x 1 (not speciated), Streptococcus salivarius x 1, and S. viridans x 1. Ten of the 15 patients returned to baseline vision (page 1225, left col., para. 1-6). Wen ‘2018 (cited here as evidence only) disclosed that age-related macular degeneration (AMD) is the leading cause of blindness in the elderly worldwide. Development of soft drusen between Bruch's membrane and retinal pigment epithelium (RPE) and loss of RPE cells in the macular region ultimately lead to irreversible vision loss. The early pathological manifestation of AMD, drusen, exhibits various appearance including hard drusen, soft drusen, cuticular drusen, reticular pseudodrusen, and ghost drusen. Many of these drusens come and go while only the soft drusen has been associated with AMD risk. In AMD treatment, anti-VEGF antibodies are the major agents stopping the neovascularization and rescuing vison loss for wet AMD (page 88, left col., para. 3; page 90, left col., para. 2; page 91, right col., para. 1).
Thus, these teachings of Klein ‘2009 evidenced by Wen ‘2018 anticipate Applicant’s claims 71-74, 76, and 80-85 and would also achieve the results, including “killing or inhibiting the growth of the microorganism in the eye, blood, and/or GI tract”, required by claim 76, because the injected intravitreally injected vancomycin and/or ceftazidime with oral ciprofloxacin or moxifloxacin restore vision to baseline, as described above.
Applicant’s Arguments/Remarks filed on 06/25/2026 have been fully considered. Applicant argued “in this application, it was shown that infection with microorganisms in the intraocular space is a pathogenic cause of AMD, and treating the infection with antibiotics can reverse the drusen formation induced by the infection thereby treating the AMD… In Klein, the AMD existed prior to the infection caused by intravitreal injection of anti-VEGF agents. Klein treats the infection independent of the preexisting AMD with antibiotics… Wen does not support that the antibiotics in Klein can effectively treat AMD” (p. 8, para. 2 to 3; p. 9, para. 1).
In response, these arguments are found not persuasive because of the following reasons. The argued “infection with microorganisms in the intraocular space is a pathogenic cause of AMD” is not supported by the originally filed application, in which the “Example 8. Bacillus megaterium induces activation of complement, pyroptosis of RPE cells in vitro and induces drusenoid lesions in macaque” cannot be the evidence for the cause of AMD because Wen ‘2018 disclosed “drusen, exhibits various appearance including hard drusen, soft drusen, cuticular drusen, reticular pseudodrusen, and ghost drusen. Many of these drusens come and go while only the soft drusen has been associated with AMD risk” above. Also, the amended claim 71 is still broad and encompasses a subject having AMD, which is anticipated by the teachings of Klein ‘2009 evidenced by Wen ‘2018. The Wen ‘2018 is cited only to provide evidence for the characteristics of AMD and drusen.
New (necessitated by amendment) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 71-77 and 80-85 are rejected under 35 U.S.C. 103 as being unpatentable over Klein et al. (Ophthalmology Volume 116, Number 6, June 2009, p. 1225-1225e1, hereinafter referred to as Klein ‘2009) in view of Wen et al. (Progress in Retinal and Eye Research 64:84–95, 2018, Available online 19 January 2018, hereinafter referred to as Wen ‘2018, also listed in IDS filed on 05/06/2024). Claims 71-74, 76, and 80-85 are rejected here because they have been rejected by the primary reference above and thus the disclosures of Klein ‘2009 have been incorporated to their entirety here.
Klein ‘2009 did not explicitly disclose the structural limitations “the microorganism is Bacillus megaterium, required by claims 75 and 77.
Wen ‘2018 disclosed that bacterium Bacillus megaterium was significantly enriched in soft drusens from age-related macular degeneration (AMD) patients, and when inoculated subretinally in a non-human primate model, Bacillus megaterium induced drusen-like pathology. The possibility that other bacteria or microorganisms could play the same key role in the formation of drusen could explain the varying shape and size of drusen observed across AMD patients (page 90, right col., para. 2).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to identify a subject, who has age-related macular degeneration and is also infected with a microorganism or Bacillus megaterium, for antibiotics as taught by Klein ‘2009 in view of Wen ‘2018 because Staphylococcus epidermidis (or Bacillus megaterium) is detected in AMD patients or subjects and intravitreal or oral antibiotic restore vision, described above. Thus, one of skill in the art would have a reasonable expectation that by combining the teachings of Klein ‘2009 and Wen ‘2018, one would achieve Applicant’s claims 71-77 and 80-85.
New (necessitated by amendment) 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 71, 74-77, and 80-85 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 137-139 of copending Application No. 17/293,603 (Wei et al., claim set of 05/11/2026) in view of Wen et al. (Progress in Retinal and Eye Research 64:84–95, 2018, Available online 19 January 2018, hereinafter referred to as Wen ‘2018, also listed in IDS filed on 05/06/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because Appl. ‘603 claims “A screening method for identifying a candidate therapeutics for treating or preventing AMD, the method comprising… c) identifying the test compound as a candidate therapeutics for treating or preventing AMD (or dry or wet AMD with soft drusen symptoms) when the test compound inhibits the growth of the population of microorganisms compared to a control, wherein the population of microorganisms comprise a plurality of species selected from Staphylococcus epidermidis, Pseudomonas aeruginosa,… Bacillus cereus, Bacillus megaterium, Lactobacillus reuteri,… Bacillus megaterium and/or Pseudomonas putida (or further comprising a step of: d) Administering the candidate therapeutics identified in step c) to an animal model of AMD that has been infected in the intraocular space with at least one of the species of the population of microorganisms in step a), and determining whether the candidate therapeutics relieves one or more symptoms of AMD of the animal model)” (claims 1, 4, and 137-139), reading on claims 71, 74-77, and 80-85 except the claimed antibiotic. Wen ‘2018 disclosed that bacterium Bacillus megaterium was significantly enriched in soft drusens from age-related macular degeneration (AMD) patients, and when inoculated subretinally in a non-human primate model, Bacillus megaterium induced drusen-like pathology. The possibility that other bacteria or microorganisms could play the same key role in the formation of drusen could explain the varying shape and size of drusen observed across AMD patients. As the infectious etiology of AMD starts to be gradually recognized, how to target specific bacteria or microbiota for AMD therapy is still unclear. Local or systemic antibiotic treatment may help to kill the pathogenic bacteria (page 90, right col., para. 2; page 91, right col., para. 3). Thus, skilled artisan would substitute the generic test compound for inhibiting the growth of the population of microorganisms of Appl. ‘603 with local or systemic antibiotic of Wen ‘2018 to treat AMD. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are 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 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.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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