Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/26/2025 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 4/9/2024 is acknowledged.
Claim 31, 35-36, 50-53, 57, 59, 61, 65, 111, 118, and 125 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II-XIII, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/9/2024.
Status of Claims
Cancelled: 2, 3, 5-23, 25-30, 32-34, 37-49, 54-56, 58, 60, 62-64, 66-110, 112-117, 119-124, 126-133, 136
Withdrawn: 31, 35-36, 50-53, 57, 59, 61, 65, 111, 118, 125
Examined Herein: 1, 4, 24, 134, 135
Priority
Priority to CN201811351660.9 filed on 11/14/2018 and PCT/CN2019/084396 filed on 4/25/2019
is acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 7/20/2022, 9/14/2022,
4/9/2024, and 8/7/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on 5/13/2021 are accepted.
Withdrawn Rejections
All rejections of claim 136 are hereby withdrawn; its cancellation moots the rejections.
The rejection of claims 1, 4, 24, and 134-136 under 35 U.S.C. 112(b) is hereby withdrawn in view of Applicant’s amendments to claim 1, which removes the limitation "wherein the... the population of microorganisms are derived, in part or in whole, from an aqueous humor and/or vitreous humor of a subject having age-related macular degeneration,” thereby rendering the rejection moot. [Remarks 11/26/2025, Page 11]
The rejection of claims 1, 24, 134, and 136 under 35 U.S.C. 102(a)(1) over Linn is hereby withdrawn in view of Applicant’s substantial amendments to claim 1, 134, and 135, and Applicant’s persuasive arguments that Linn does not teach the claim limitations as amended. [Remarks 11/26/2025, Page 11-12]
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.
Claims 1, 4, 24, 134, and 135 are rejected under 35 U.S.C. 103 as being unpatentable over Linn (The varying sensitivity to antibacterial agents of micro-organisms in pure vs. mixed cultures, June 1975, Surgery, Volume 77, Number 6), in view of Sorokulova (US 2005/0271643 A1, Published 12/8/2005).
With respect to claim 1, Linn discloses a method comprising:
a) Culturing a population of microorganisms, selected from Pseudomonas aeruginosa and Staphylococcus aureus, in a suitable culture medium, trypticase soy broth, in the presence of a test compound, penicillin, streptomycin, gentamycin, kanamycin, silver nitrate, sulfamylon, or betadine.
b) Measuring the growth of the population of microorganisms in the culture medium of the test compound; and
c) Identifying a candidate therapeutic, or antimicrobial agent, that inhibits the growth of the population of microorganisms compared to a control, Pseudomonas aeruginosa or Staphylococcus alone;
wherein the population of microorganisms comprises a plurality of species selected from Pseudomonas aeruginosa and Staphylococcus aureus. [Linn, Page 780, Col. 2, Paragraph 2 and Page 781, Col. 1, Paragraph 1-3 and Page 782 & 783, Table 1]
With respect to claim 24, Linn discloses a plurality of test compounds are screened including silver nitrate and betadine. [Linn, Page 780, Col. 2, Paragraph 2 and Page 781, Col. 1, Paragraph 1-3 and Page 782 & 783, Table 1] Silver nitrate and betadine are not antibiotics, and thus are neither a known broad-spectrum antibiotic nor a known antibiotic having efficacy against one or more species of the at least one microorganism.
Linn does not disclose the plurality of species include Bacillus megaterium and/or Pseudomonas Putida.
However, with respect to claim 1, 4, 134, and 135, Sorokulova discloses a bacterial co-culture is a bacterial cell culture, which includes at least two bacterial strains. [Sorokulova, 0084] Sorokulova further discloses a bacterial co-culture may include Pseudomonas aeruginosa, Pseudomonas putida, and/or Bacillus megaterium. [Sorokulova, 0085]
Modifying the method disclosed by Linn by including Bacillus megaterium and/or Pseudomonas putida in the plurality of species comprised in the population of microorganisms, results in the method of claim 1, 4, 24, 134, and 135.
It would be obvious to one of ordinary skill in the art to modify the method disclosed by Linn by including Bacillus megaterium and/or Pseudomonas putida in the plurality of species comprised in the population of microorganisms, and have a reasonable expectation of success. Linn discloses a method comprising co-culturing a population of microorganisms including bacterial strains Pseudomonas aeruginosa and Staphylococcus aureus. Sorokulova discloses a bacterial co-culture may include Pseudomonas aeruginosa, Pseudomonas putida, and Bacillus megaterium. So, Linn discloses a co-culture that comprises Pseudomonas aeruginosa and Sorokulova discloses such a culture may further comprise Pseudomonas putida and Bacillus megaterium. Thus, the combined teachings of Linn and Sorokulova suggest Pseudomonas putida and Bacillus megaterium may be included in the co-culture disclosed by Linn. Therefore, it is reasonable to expect the method disclosed by Linn may be modified by including Bacillus megaterium and/or Pseudomonas putida in the plurality of species comprised in the population of microorganisms. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. In the instant case, Linn discloses a co-culture of bacterial strains and Sorokulova discloses co-cultures of bacterial strains exhibit a wide range of antimicrobial activity, even higher than that of the parental culture. [Sorokulova, 0076] Sorokulova further discloses bacterial co-cultures are known in the art to include Bacillus megaterium and Pseudomonas putida. [Sorokulova, 0085] Therefore, one of ordinary skill in the art would be motivated by the expectation that the aforementioned modification would result in a co-culture, comprising Bacillus megaterium and/or Pseudomonas putida, that exhibits an enhanced antimicrobial activity.
The limitations “…for identifying a candidate therapeutics for treating or preventing age-related macular degeneration (AMD)… for treating or preventing AMD” recite an intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In the instant case, there is no structural difference between the claimed invention and the method disclosed by Linn and Sorokulova. Thus, the claimed invention is patentably indistinguishable from these references.
Claims 1, 4, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Belenky (US 2018/0187237 A1, Published 7/5/2018), in view of Olstein (US 2005/0026813 A1, Published 2/3/2005).
With respect to claim 1, Belenky discloses a screening method comprising:
a) Culturing a population of microorganisms in a suitable culture medium in the
presence of a test compound;
b) Measuring the growth of the population of microorganisms in the culture
medium in the presence of the test compound; and
c) Identifying a candidate therapeutic that inhibits the growth of the population
of microorganisms compared to a control; [Belenky, 0051, 0186]
wherein the population of microorganisms comprise a plurality of pathogenic bacteria selected
from Staphylococcus epidermidis, Pseudomonas aeruginosa, Staphylococcus aureus,
Bacillus cereus, and Enterococcus faecium. [Belenky, 0060]
Moreover, Belenky discloses essentially any bacteria can be detected and the methods and compositions can be used for determining antibiotic susceptibility of bacteria or for screening a candidate antibiotic agent that exerts a desirable (e.g., antimicrobial or cytotoxic) effect on target bacteria. [Belenky, 0057]
With respect to claim 24, Belenky discloses a plurality of test compounds are screened. [Belenky, 0051] Belenky discloses the test compound is selected from the group consisting of β-lactams, fluoroquinolones, aminoglycosides, tetracyclines, glycylcyclines, polymyxins, and include for example, penicillin V, penicillin G, and methicillin, which are neither known broad spectrum antibiotics nor a known antibiotic having efficacy against one or more species of the at least one microorganism. [Belenky, 0078, 0080; see also 0076-0087]
Belenky does not disclose the plurality of species include Bacillus megaterium.
However, with respect to claim 1 and 4, Olstein discloses B. megaterium is a pathogenic bacterium, along with B. cereus, S. aureus, and S. epidermidis. [Olstein, 0105]
Modifying the method disclosed by Belenky by including Bacillus megaterium in the plurality of species comprised in the population of microorganisms, results in the method of claim 1, 134, and 135.
It would be obvious to one of ordinary skill in the art to modify the method disclosed by Belenky by including Bacillus megaterium in the plurality of species comprised in the population of microorganisms and have a reasonable expectation of success. Belenky discloses a screening method comprising culturing a population of microorganisms that comprises a plurality of pathogenic bacteria including Staphylococcus epidermidis, Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus cereus, and/or Enterococcus faecium. Belenky further discloses essentially any bacteria can be used in the method. Olstein discloses B. megaterium is a pathogenic bacterium, along with B. cereus, S. aureus, and S. epidermidis. Since, Belenky discloses a method comprising culturing a population of pathogenic bacteria and Olstein discloses B. megaterium is a pathogenic bacterium, the combined teachings of Belenky and Olstein suggest B. megaterium may be one of the pathogenic bacteria included in the population of microorganisms disclosed by Belenky. One would have been motivated to do so because the selection of a known material based on its suitability for its intended use is prima facie obvious. In the instant case, Belenky discloses pathogenic bacteria may be used in the screening method and Olstein discloses B. megaterium is a pathogenic bacterium. Therefore, the selection of B. megaterium based on its suitability as a pathogenic bacterium for use in the screening method disclosed by Belenky is prima facie obvious.
The limitations “…for identifying a candidate therapeutics for treating or preventing age-related macular degeneration (AMD)… for treating or preventing AMD” recite an intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In the instant case, there is no structural difference between the claimed invention and the method disclosed by Belenky and Olstein. Thus, the claimed invention is patentably indistinguishable from these references.
Claims 1, 4, 24, 134, and 135 are rejected under 35 U.S.C. 103 as being unpatentable over Belenky and Olstein, as applied to claim 1, 4, and 24 above, and further in view of Serwer (US 2016/0030495 A1, Published 2/4/2016).
With respect to claim 1, Belenky and Olstein disclose the teachings above.
Belenky and Olstein do not disclose the plurality of species include Pseudomonas Putida.
However, with respect to claim 1, 134, and 135, Serwer discloses Pseudomonas putida is a pathogenic bacterium. [Serwer, 0070]
Modifying the method disclosed by Belenky and Olstein by including Pseudomonas putida in the plurality of species comprised in the population of microorganisms, results in the method of claim 1, 134, and 135.
It would be obvious to one of ordinary skill in the art to modify the method disclosed by Belenky and Olstein by including Pseudomonas putida in the plurality of species comprised in the population of microorganisms and have a reasonable expectation of success. Belenky/Olstein disclose a screening method comprising culturing a population of microorganisms that comprises a plurality of pathogenic bacteria including Staphylococcus epidermidis, Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus cereus, Enterococcus faecium, and/or B. megaterium. Belenky further discloses essentially any bacteria can be used in the method. Serwer discloses Pseudomonas putida is a pathogenic bacterium. Since, Belenky/Olstein disclose a method comprising culturing a population of pathogenic bacteria and Serwer discloses Pseudomonas putida is a pathogenic bacterium, the combined teachings of Belenky/Olstein and Serwer suggest Pseudomonas putida may be one of the pathogenic bacteria included in the population of microorganisms disclosed by Belenky/Olstein. One would have been motivated to do so because the selection of a known material based on its suitability for its intended use is prima facie obvious. In the instant case, Belenky/Olstein disclose pathogenic bacteria may be used in the screening method and Serwer discloses Pseudomonas putida is a pathogenic bacterium. Therefore, the selection of Pseudomonas putida based on its suitability as a pathogenic bacterium for use in the screening method disclosed by Belenky/Olstein is prima facie obvious.
The limitations “…for identifying a candidate therapeutics for treating or preventing age-related macular degeneration (AMD)… for treating or preventing AMD” recite an intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In the instant case, there is no structural difference between the claimed invention and the method disclosed by Belenky, Olstein, and Serwer. Thus, the claimed invention is patentably indistinguishable from these references.
Response to Arguments
Applicant’s arguments, filed 11/26/2025, with respect to the rejection of claims 1, 24, 134, and 136 under 35 U.S.C. § 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. [Remarks 11/26/2025, Page 11-12]
Applicant's arguments filed, 11/26/2025, with respect to the rejection of claims 1, 4, 24, 134, 135 and 136 under 35 U.S.C. § 103 have been fully considered but they are not persuasive.
Applicant asserts “Applicant respectfully submits that Linn and Sorokulova concern entirely different subject matter and a person of ordinary skill in the art would not have combined Linn and Sorokulova as the Examiner proposed to arrive at the claimed invention.” [Remarks, Page, 13, Paragraph 1]
Applicant’s argument is not persuasive because Applicant is incorrect that Linn and Sorokulova must concern analogous subject matter to be combined by a POSITA. However, MPEP 2141.01(a) states “When more than one prior art reference is used as the basis of an obviousness rejection, it is not required that the references be analogous art to each other.” Rather, the references must be analogous art to the claimed invention. Thus, even if Linn and Sorokulova were drawn to entirely different subject matter, this would not preclude obviousness so long as the references are analogous art to the claimed invention. In any event, Linn and Sorokulova are both drawn to bacterial co-cultures. This subject matter is in the same field of endeavor and reasonably pertinent to the claimed invention. Therefore, Linn and Sorokulova do not concern entirely different subject matter and both references are analogous art with the claimed invention, as required for use in an obviousness rejection under 35 U.S.C. 103.
Applicant asserts “The microorganisms tested in Linn are those that may cause infection in real clinical situations. On the other hand, Sorokulova concerns probiotics, which are beneficial to human health and are used for treating diseases or disorders listed therein. Sorokulova teaches that Bacillus megaterium as one of the "other strains of probiotics bacteria", not that Bacillus megaterium needs to be inhibited.” [Remarks, Page 13, Paragraph 2-3]
Applicant’s argument is not persuasive because Applicant attempts to distinguish the microorganisms in Linn from the microorganisms in Sorokulova by stating that the former “may cause infection in real clinical situations”, whereas the latter “concerns probiotics, which are beneficial to human health.” However, a POSITA would understand that Bacillus megaterium and other probiotics are not universally beneficial to human health and may require inhibition. The microorganisms disclosed by Sorokulova are pathogenic just like the microorganisms disclosed by Linn. A POSITA of ordinary skill in the art would reasonably conclude that the microorganisms disclosed by Sorokulova are just as suitable to be screened according to the method disclosed by Linn. The alleged distinction purported by the Applicant would not preclude a POSITA from combining the teachings of Linn and Sorokulova to arrive at the claimed invention.
In any event, newly cited reference Belenky discloses essentially any bacteria can be used for determining antibiotic susceptibility of bacteria or for screening a candidate antibiotic agent that exerts a desirable (e.g., antimicrobial or cytotoxic) effect on target bacteria. [Belenky, 0057]
Applicant asserts “If anything, these probiotics bacteria should be kept alive such that their beneficial effects can be maintained.” [Remarks, Page 13, Paragraph 3]
Applicant’s argument is unpersuasive because the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. While Applicant may be of the opinion that Bacillus megaterium should be kept alive such that their beneficial effects can be maintained, it is not necessary that the prior art teach the same sentiment.
Applicant asserts “Sorokulova does not teach anything further about Bacillus megaterium, much less to specifically include such species with the mixture culture in Linn.” [Remarks, Page 13, Paragraph 3]
Applicant’s argument is unpersuasive at least because Linn discloses a bacterial co-culture comprising Pseudomonas aeruginosa. Sorokulova discloses a bacterial co-culture which may comprise Pseudomonas aeruginosa, Bacillus megaterium, and Pseudomonas putida. Thus, the combined teachings of Linn and Sorokulova suggest Bacillus megaterium and Pseudomonas putida may be present in the bacterial co-culture with Pseudomonas aeruginosa disclosed by Linn. A POSITA would reasonably arrive at the claimed invention because of these teachings.
Applicant asserts “Applicant further amended claim 1 to specify that the screening method is for identifying potential drugs for treating or preventing AMD. Applicant submits that none of the cited references teaches the claimed method to specifically screening for test compounds that can inhibit the growth of the recited microbial species and identifying such inhibitors as potential drugs for treating or preventing AMD.” [Remarks, Page 13, Paragraph 4]
Applicant’s amendments do not overcome the rejection of record because they merely recite an intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In the instant case, there is no structural difference between the claimed invention and the prior art. Thus, the claimed invention is patentably indistinguishable from the prior art.
Conclusion
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/K.A.C./Examiner, Art Unit 1618 /Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618