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 . Preliminary amendment filed on 07/30/2024 has been entered. Claims 1-70 are cancelled. Claims 71-85 are new, are pending in this application, and are currently under examination.
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 71-85 recite “treating or preventing 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 Amikacin, Amoxicillin, Ampicillin, Arsphenamine… Teixobactin, Malacidins, and combinations thereof; or selected from ciprofloxacin, ceftazidime, ampicillin, chloramphenicol, and vancomycin)”, “the subject is identified as being infected with, in the intraocular space, a microorganism selected from 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 microorganism in the eye, blood, and/or GI tract), “an effective amount of an active compound selected from compounds (1)-(8) or a pharmaceutically acceptable salt thereof, or a pharmaceutical composition comprising the compound or pharmaceutically acceptable salt thereof wherein compounds (1)-(8) have the following chemical structure:
PNG
media_image1.png
200
400
media_image1.png
Greyscale
(1),
PNG
media_image2.png
200
400
media_image2.png
Greyscale
(2),
PNG
media_image3.png
200
400
media_image3.png
Greyscale
(3),
PNG
media_image4.png
200
400
media_image4.png
Greyscale
(4),
PNG
media_image5.png
200
400
media_image5.png
Greyscale
(5),
PNG
media_image6.png
200
400
media_image6.png
Greyscale
(6),
PNG
media_image7.png
200
400
media_image7.png
Greyscale
(7), and
PNG
media_image8.png
200
400
media_image8.png
Greyscale
(8)”, 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 71-85 is 12/03/2018.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 05/06/2024 has been considered.
Claim Objections
Claims 72-74, 77, 79, and 84 are objected to because of the following informalities: In claims 72-74 and 79, insert the missing phrase “the group consisting of” immediately after the recitation “selected from” (line 1 of claim 72 and 73; line 2 of claims 74 and 79) to comply with the Markush group format ending with the conjunction “and” before the last species. In claim 77, change the incorrect recitation “claim 76, wherein” (line 1), in which the wherein clause duplicates the claim 76, to “claim 75, wherein”. In claim 84, change the incorrect conjunction “and/or” (line 2) to “or” because the “and” would erroneously combine the mixed drusen with additional hard or soft drusen. Appropriate correction is required.
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 71-85 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 reducing the probability of or ameliorating age-related macular degeneration (AMD) in a subject in need thereof, does not reasonably provide enablement for treating or preventing age-related macular degeneration (AMD) in a subject in need thereof. The term “treating” is defined “the terms "treat," "treating," "treatment," and the like refer to eliminating, reducing, or ameliorating a disease or condition, and/or symptoms associated therewith… may include "prophylactic treatment," which refers to reducing the probability of redeveloping a disease or condition” in the specification (p. 182/193 to 183/193, [563]). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or to use the invention commensurate in scope with these claims. Claims 72-85 depend from claim 71.
Applicants claim a method of treating (encompassing eliminating or preventing) AMD in a subject recited in claim 71. However, no limiting definition of “preventing" or “prevention” is given in the instant Specification. In the absence of a limiting definition by the Applicants, "prevention" as described according to the Institute for International Medical Education (pages 15 and 16, also listed in IDS filed on 05/06/2024), is a preventive measure, such as preserving physical fitness in primary prevention and effective intervention to correct departures from good health in secondary prevention. More specifically, tertiary prevention, which is most relevant as used in the context of the instant invention, "consists of the measures available to reduce or eliminate long-term impairments and disabilities, [and to] minimize suffering caused by existing departures from good health". Thus, the claimed method of treating (encompassing eliminating or preventing) AMD in a subject as interpreted by a skilled practitioner of the medical or pharmaceutical arts would be to reduce for long-term the occurrence of or to eliminate AMD in a subject by the method.
The Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: The rejected invention is drawn to A method for treating or preventing 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.
Relative skill of those in the art: The relative skill of those in the art is from biomedical field.
Breadth of claims: The claim is extremely broad in that it encompasses the elimination or prevention of AMD in a subject using the claimed method.
State of the prior art/Predictability or unpredictability of the art: There is no teaching or suggestion in the state of the prior art that application of certain pharmaceutical method can eliminate or prevent AMD in a subject. Wen et al. (Progress in Retinal and Eye Research 64:84–95, 2018, Available online 19 January 2018, also listed in IDS filed on 05/06/2024) disclosed that Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly worldwide. The identification of strong genetic associations of complement factor H (CFH) and ARMS2-HTRA1 with AMD leads researchers to consider AMD as a genetic disease. The majority of Caucasian AMD patients suffer the dry form of AMD (geographic atrophy), while Asian AMD patients are more likely to suffer wet AMD or polypoidal choroidal vasculopathy (PCV). The strongest genetic risk factor of AMD in Caucasians, CFH Y402H, is not associated with Asian AMD. Similarly, genetic polymorphism in the HTRA1 gene only associates with Asian PCV but not Caucasian AMD. . In AMD treatment, anti-VEGF antibodies are the major agents stopping the neovascularization and rescuing vison loss for wet AMD. Unfortunately, effective therapies for dry AMD have yet to be discovered. As the infectious etiology of AMD starts to be gradually recognized, how to target specific bacteria or microbiota for AMD therapy is still unclear (page 88, left col., para. 3; page 89, right col., para. 3; page 90, left col., para. 1; page 91, right col., para. 1 and 2). One of skilled artisan would understand that contemporary treatment or management of AMD is to slow progression of or to minimize AMD symptoms, not to eliminate or to prevent AMD.
Amount of guidance/Existence of working examples: It is worth noting that there are no working examples in this application to show that the claimed method is effective for eliminating or preventing AMD in a subject as recited in the claim. The exemplary embodiments of the Specification merely present: (i) Example 7. Bacillus megaterium is enriched in soft drusen from AMD patients. The relative abundance of B. megaterium was elevated by ~18 fold in soft drusen when compared to the non-drusen/non-lesion tissues. These data suggest a possible role of B. megaterium in drusen formation and AMD pathogenesis; (ii) Example 9. The test of Antibiotics to treat AMD through inhibiting the growth of microbiota. Vancomycin is able to inhibit the growth of Bacillus megaterium in vitro and in vivo, therefore can be used to treat age-related macular degeneration; and (iii) Example 10. In vitro Screening of Compounds that Can Inhibit the growth of microbiota. Compounds 1-8 were found to be the most active compounds in killing or inhibiting the growth of Bacillus megaterium (p. 187/193 to 192/193).
Quantity of experimentation: In order to practice the full scope of the invention, one skilled in the art would need to undertake a novel and extensive research program to show that a curing or preventive measure can be achieved after applying the claimed method. Furthermore, one of ordinary skill in the art would need to test a representative number of animals before one of ordinary skill in the art would be able to conclude that any method can be used to eliminate or to prevent AMD in a subject. Because this research would have to be exhaustive, and because it would involve such a wide and unpredictable scope of use in elimination or prevention of AMD in a subject, it would constitute an undue and unpredictable experimental burden.
Lack of a working example is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art. See MPEP § 2164. Genetech, 108 F.3d at 1366, states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable". Therefore, in view of the Wands factors as discussed above, including the amount of guidance provided and the predictability of the art and the lack of working examples to practice the full scope of the claimed invention herein, a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 75 and 77 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 pre-AIA the applicant regards as the invention. Claim 77 depends from claim 75.
Claim 75 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: Claim 75 recites “the microorganism comprises”, in which the “comprises” is open-ended and omits the structural relationship with the closed transitional phrase “selected from the group consisting of” in the preceding claim 74. Applicant is advised to change the recitation “comprises” (line 1 of claim 75) to “is”.
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 are 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)” (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. 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. 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.
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.
(I) Claims 71-78 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) and Greenway et al. (US 2007/0031332, Feb. 8, 2007, hereinafter referred to as Greenway ‘332, 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 (a) the microorganism is Bacillus megaterium, required by claims 75 and 77, and (b) a therapeutically effective amount of a compound selected from compound (6) (
PNG
media_image6.png
200
400
media_image6.png
Greyscale
= Octyl gallate, elected) or compound (7) (
PNG
media_image7.png
200
400
media_image7.png
Greyscale
= Pentagalloyl glucose), required by claim 78.
With regard to the limitation (a) above, 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).
With regard to the limitation (b) above, Greenway ‘332 disclosed a method of ameliorating angiogenesis in a mammal, said method comprising administering to the mammal a therapeutically effective amount of gallic acid or derivatives thereof, wherein the angiogenesis is associated with a disease selected from the group consisting of diabetic retinopathy, macular degeneration (or age-related macular degeneration), retinopathy of prematurity, corneal neovascularization, vein occlusion in the eye, mycobacterial infection, uveitis, infections of the retina, and myopia; and wherein the gallic acid derivative is selected from a list consisting of tannic acid, methyl gallate, propyl gallate, butyl gallate, octyl gallate, ethyl gallate, lauryl gallate, ellagic acid, BUSMUTH-gallate, galloyl glucose, di-galloyl glucose, tri-galloyl glucose, tetra-galloyl glucose, penta-galloyl glucose, and glyceryl trigallate. Said administration is by injection, orally, or by subcutaneous injection (page 73/78, right col., para. #1 to #3, #9, #10, #13, and #14; page 53/78, [0007]).
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 in combination with octyl gallate or pentagalloyl glucose treatment also in view of Greenway ‘332 because (a) Staphylococcus epidermidis (or Bacillus megaterium) is detected in AMD patients or subjects and intravitreal or oral antibiotic restore vision, and (b) both antibiotic and gallic acid derivative selected from octyl gallate or penta-galloyl glucose have been used in AMD treatment, described above. Thus, one of skill in the art would have a reasonable expectation that by combining the teachings of Klein ‘2009, Wen ‘2018, and Greenway ‘332, one would achieve Applicant’s claims 71-78 and 80-85.
(II) Claims 71-77 and 79-85 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) and Chao et al. (US 9,844,577, Dec. 19, 2017, hereinafter referred to as Chao ‘577). 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 (a) the microorganism is Bacillus megaterium, required by claims 75 and 77, and (b) an extract from one or more traditional Chinese medicine (TCMs) selected from Licorice (e.g. Glycyrrhiza uralensis), Fructus Aurantii, or Rehmannia glutinosa, required by claim 79.
With regard to the limitation (a) above, 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).
With regard to the limitation (b) above, Chao ‘577 disclosed a medicinal composition for preventing or treating a disease, disorder or condition induced by retina ischemia, wherein the medicinal composition comprising 4.5 units by weight of Radix Angelicae Sinensis (Dang Gui), 4.5 units by weight of Radix Rehmanniae glutinosae (Di Huang), 3 units by weight of Radix Paeoniae Rubra (Chi Shao), from 2.25 to 2.3 units by weight of Rhizoma Ligustici Chuanxiong (Chuan Xiong), 6 units by weight of Semen Pruni Persicae (Tao Ren), 4.5 units by weight of Flos Carthami Tinctorii (Hong Hua), 1.5 units by weight of Radix Glycyrrhizae Uralens is (Gan Cao), 3 units by weight of Fructus Aurantii (Zhi Qiao), 1.5 units by weight of Radix Bupleuri Chinense (Chai Hu), 4.5 units by weight of Radix Achyranthis Bidentatae (Niu Xi), and from 2.25 to 2.3 units by weight of Radix Platycodi Grandiflori (Jie Geng). The disease, disorder or condition is central retinal artery occlusion (CRAO), central retinal vein occlusion (CRVO), proliferative diabetic retinopathy (DR) or age-related macular degeneration (AMD) (page 1/35, Abstract; page 27/35, col. 8, lines 48-53).
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 in combination with Licorice (e.g. Glycyrrhiza uralensis), Fructus Aurantii, or Rehmannia glutinosa treatment also in view of Chao ‘577 because (a) Staphylococcus epidermidis (or Bacillus megaterium) is detected in AMD patients or subjects and intravitreal or oral antibiotic restore vision, and (b) both antibiotic and Glycyrrhiza uralensis, Fructus Aurantii, and/or Rehmannia glutinosa have been used in AMD treatment, described above. Thus, one of skill in the art would have a reasonable expectation that by combining the teachings of Klein ‘2009, Wen ‘2018, and Chao ‘577, one would achieve Applicant’s claims 71-77 and 79-85.
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 57, 59, and 61 of copending Application No. 17/293,603 (Wei et al., claim set of 11/26/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because Appl. ‘603 claims “A method of treating or preventing AMD, comprising: 1) identifying or having identified a subject as being infected with one or more species selected from Staphylococcus epidermidis, Pseudomonas aeruginosa,… Bacillus cereus, Bacillus megaterium, Lactobacillus reuteri,… in the intraocular space, and 2) administering to the subject an effective amount of an antibiotic” (claim 57), and “A method of (i) treating a drusen symptom (e.g., soft drusen) in a subject in need thereof, or (ii) reducing a drusenoid lesion, drusen-like nodules, pyroptosis of the retinal pigment epithelium cells in the eye… in a subject in need thereof, the method comprising administering to the subject an effective amount of an antibiotic (or wherein the subject suffers from AMD (e.g., dry AMD or wet AMD), has soft drusen deposited between retinal pigment epithelium (RPE) and the Bruch's membrane… infected in the intraocular space with one or more species selected from Staphylococcus epidermidis, Pseudomonas aeruginosa,… Bacillus cereus, Bacillus megaterium, Lactobacillus reuteri… ; and Xanthomonas oryzae”, encompassing or overlapping with claims 71, 74-77, and 80-85 of this Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YIH-HORNG SHIAO whose telephone number is (571)272-7135. The examiner can normally be reached Mon-Thur, 08:30 am to 07:00 pm EST.
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, Renee Claytor can be reached at 571-272-8394. 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.
/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691