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 .
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Claim 31, 35-36, 50-53, 57, 59, 61, 65, 111, 118, and 125 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II-XIII, there being no allowable generic or linking claim.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, 25-133, 136
New: 137-139
Examined Herein: 1, 4, 24, 134, 135, 137-139
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.
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, 135, 137, and 138 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, 137, and 138, 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 the test compound as a candidate therapeutic (antimicrobial agent), when it inhibits the growth of the population of microorganisms compared to a control, Pseudomonas aeruginosa or Staphylococcus aureus alone;
wherein the population of microorganisms comprises a plurality of species including 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 that 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 plurality of species.
Linn does not disclose that the plurality of species includes Bacillus megaterium and/or Pseudomonas Putida.
However, with respect to claims 1, 4, 134, 135, 137, and 138 Sorokulova discloses that a bacterial co-culture is a bacterial cell culture that 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, 135, 137, and 138.
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 that a bacterial co-culture may include Pseudomonas aeruginosa, Pseudomonas putida, and/or Bacillus megaterium. Thus, Linn discloses a bacterial co-culture, and Sorokulova establishes that Pseudomonas aeruginosa, Pseudomonas putida, and Bacillus megaterium are recognized in the art as compatible additions to a bacterial co-culture. Accordingly, the combined teachings of Linn and Sorokulova suggest that Pseudomonas putida and Bacillus megaterium may be included in the co-culture disclosed by Linn. Therefore, it is reasonable to expect that the method disclosed by Linn may be modified by including Bacillus megaterium and/or Pseudomonas putida among the plurality of species comprising 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. MPEP 2144(II). In the present case, Linn discloses a co-culture of bacterial strains, and Sorokulova discloses that co-cultures exhibit a wide range of antimicrobial activity, even greater 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.
With respect to claim 1, the limitations “…for treating or preventing AMD” constitute an intended use and an instruction limitation. 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 present case, there is no structural difference between the claimed invention and the method disclosed by Linn and Sorokulova. Moreover, these limitations do not transform the way the method is performed. Thus, the claimed invention is patentably indistinguishable from the prior art.
With respect to claims 137 and 138, the recited limitations are merely a narrower recitation of the intended use and the instruction limitation explained above. Likewise, the limitations do not transform the way in which the method is performed; thus, they are patentably indistinct from the prior art.
Claims 1, 4, 24, 137, and 138 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 claims 1, 137, and 138, 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 the test compound as a candidate therapeutic when it inhibits the growth of the population of microorganisms compared to a control; [Belenky, 0051, 0186]
wherein the population of microorganisms comprises a plurality of pathogenic bacteria selected
from Staphylococcus epidermidis, Pseudomonas aeruginosa, Staphylococcus aureus,
Bacillus cereus, and Enterococcus faecium. [Belenky, 0060]
Moreover, Belenky discloses that essentially any bacteria can be detected, and that the methods and compositions can be used to determine the antibiotic susceptibility of bacteria or to screen 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 that 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 includes, 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 that the plurality of species includes Bacillus megaterium.
However, with respect to claims 1, 4, 137, and 138, Olstein discloses that 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 comprising the population of microorganisms results in the method of claim 1, 134, 135, 137, and 138.
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 comprising 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. Therefore, it is reasonable to expect that the method disclosed by Belenky may be modified by including Bacillus megaterium among the plurality of species comprising the population of microorganisms. 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. MPEP 2144.07. 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.
With respect to claim 1, the limitations “…for treating or preventing AMD” recite an intended use and an instruction limitation. 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 present case, there is no structural difference between the claimed invention and the method disclosed by Belenky and Olstein. Moreover, the limitations do not transform the way the method is performed. Thus, the claimed invention is patentably indistinguishable from the prior art.
With respect to claims 137 and 138, the recited limitations are merely a narrower recitation of the intended use and the instruction limitation explained above. Likewise, the limitations do not transform the way in which the method is performed; thus, they are patentably indistinct from the prior art.
Claims 1, 4, 24, 134, 135, 137, and 138 are rejected under 35 U.S.C. 103 as being unpatentable over Belenky and Olstein, as applied to claim 1, 4, 24, 137, and 138 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 that the plurality of species includes Pseudomonas Putida.
However, with respect to claim 1, 134, and 135, Serwer discloses that 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 comprising 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 comprising 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.
Allowable Subject Matter
Claim 139 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed on 5/11/2026 have been fully considered but they are not persuasive.
Applicant asserts “Rather, Applicant argued that a person of ordinary skill in the art would not have been motivated to make the combination the Examiner proposed based on the teachings of these two references. Specifically, a person of ordinary skill in the art would not have added Bacillus megaterium, a probiotic, into Lynn's coculture, for testing sensitivity of antibacterial agents mimicking infections in real clinical situations. The Office Action states that "a POSIT A would understand that Bacillus megaterium and other probiotics are not universally beneficial to human health and may require inhibition." (Office Action, p. 11.) The Examiner cites no reference to support that Bacillus megaterium may require inhibition, much less the circumstances where it requires inhibition.” [Remarks 5/11/2026, Page 4, Paragraph 5]
The following references provide support for the Examiner’s previous assertion that “a POSITA would understand that Bacillus megaterium and other probiotics are not universally beneficial to human health and may require inhibition."
“Mostly on an empirical base, probiotics are widely used for treating mucosal inflammation, particularly in the gastrointestinal tract and in the vagina…. However, in chronic and advanced form of these diseases even the continuous use of probiotics may be ineffective due to severe, treatment-resistant pathological alterations of the gastro-intestinal mucosa. In those cases, probiotics may actually aggravate local inflammatory diseases; furthermore, several cases of sepsis, due to probiotics, have also been reported, particularly in immune-compromised persons.” [US 2012/0114776 A1, 0005]
“Probiotics are known to have several important effects on a cellular level—NF.sub.KB activation, upregulation of cytoprotective genes, prevention of apoptosis, generation of reactive oxygen species and expression of tight junctions (Patel, 2012). Several reports of probiotic associated sepsis have however raised concerns regarding routine clinical use of live bacteria in hosts, such as premature infants, who have immature epithelial-barrier defenses (Patel, 2012).” [US 2020/0316172 A1, 0029]
“Yet another aspect of the invention provides a method of inhibiting microbial growth. The method comprising contacting microbe to be inhibited with a microbial inhibiting amount of a compound according to Formula I, or salt or prodrug thereof. [0024] Preferably the microbe to be inhibited is… Bacillus megaterium…” [US 2006/0089415 A1, 0024]
“In one aspect of the present invention, Mitrecin A polypeptides are applied in a method for the treatment or prophylaxis of one or more bacteria, which are selected from the group consisting of a Gram-positive bacterium, a Gram-negative bacterium, or both. Examples of Gram-positive target bacteria that can be killed or inhibited include, but are not limited to… Bacillus megaterium…” [US 2014/0094401 A1, 0138]
In view of the foregoing, it is evident that probiotics are not universally beneficial to human health and may cause sepsis and aggravate local inflammatory diseases. Moreover, Bacillus megaterium is a known target for inhibition, thereby establishing an art-recognized motivation to inhibit it.
Applicant asserts “On the other hand, none of the cited references discloses any role of Bacillus megaterium in any particular disease such that a person of ordinary skill in the art would desire an inhibitor of this probiotic.” [Remarks 5/11/2026, Page 4, Paragraph 5 – Page 5, Paragraph 1]
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be reasoned from knowledge generally available to one of ordinary skill in the art or established scientific principles. Bacillus megaterium is a microbe (or germ). Germs can lead to an infection. If microbes are killed or inhibited, they are less likely to lead to infection. This is a well-established and widely understood scientific principle.
Applicant asserts “The Examiner also relies on Sorokulova [0085] for the proposition that "a bacterial co-culture may include Pseudomonas aeruginosa, Pseudomonas putida, and/or Bacillus megaterium." That paragraph, however, is a generic recitation of "OTHER strains of probiotics bacteria" that the Sorokulova B. licheniformis + B. subtilis probiotic co-culture may optionally further include. Paragraph [0085] of Sorokulova does not provide a person of ordinary skill in the art to identify an inhibitor of Bacillus megaterium, let alone to specifically combine Bacillus megaterium with Linn's co-culture in a specific fashion to arrive at the claimed invention.” [Remarks 5/11/2026, Page 5, Paragraph 2]
In considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom. MPEP 2144.01.
Sorokulova discloses that “It will be appreciated that the bacterial co-culture of the present invention may include other strains of probiotics bacteria… Examples of probiotic bacterial strains include but are not limited to… Bacillus megaterium…Pseudomonas aeruginosa, Pseudomonas putida…” [0085] In view of the foregoing, a POSITA would recognize that (1) Sorokulova discloses a bacterial co-culture and (2) said bacterial co-culture may further comprise Bacillus megaterium. From this, a POSITA can reasonably conclude that a bacterial co-culture may include Pseudomonas aeruginosa, Pseudomonas putida, and/or Bacillus megaterium or that bacterial co-cultures comprising Pseudomonas aeruginosa, Pseudomonas putida, and/or Bacillus megaterium are known in the art. [Sorokulova, 0085] Accordingly, Sorokulova establishes that these microorganisms were recognized as suitable additions to a bacterial co-culture, such as the bacterial co-culture disclosed by Linn. Linn and Sorokulova are both directed to bacterial co-cultures. A POSITA seeking to modify the co-culture disclosed by Linn would have looked to Sorokulova’s disclosure of microorganisms that serve as suitable additions to a bacterial co-culture. Nothing in Sorokulova suggests that for Bacillus Megaterium to be present in a bacterial co-culture, Bacillus licheniformis PA or Bacillus subtilis HE must necessarily also be present.
Moreover, the use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. MPEP 2123(I). Even if Applicant believes that paragraph [0085] refers to “a generic recitation of "OTHER strains of probiotics bacteria that the Sorokulova B. licheniformis + B. subtilis probiotic co-culture may optionally further include,” this is not the only reasonable suggestion that a POSITA could glean from the disclosure.
Applicant asserts the following:
“The claims require a step of "Identifying the test compound as a candidate therapeutics for treating or preventing AMD, when the test compound inhibits the growth of the population of microorganisms compared to a control." This identifying step explicitly requires that the test compound be identified as a potential therapeutics for treating or preventing AMD, not for any other diseases.” [Remarks 5/11/2026, Page 5, Paragraph 4]
“In addition, Belenky in view of Olstein and Serwer does not teach or suggest the correlation between inhibition of Bacillus megaterium and AMD. As with the rejections based on Linn and Sorokulova, the Office Action does not properly weigh the limitations "for identifying a candidate therapeutic for treating or preventing age-related macular degeneration (AMD)" and "for treating or preventing AMD". As discussed above, the claims require an identifying step that explicitly requires that the test compound be identified as a potential therapeutics for treating or preventing AMD, not for any other diseases. Should the Office properly consider the patentability weight of the features related to AMD, the Office would have found that the claimed methods are nonobvious over the cited references.” [Remarks 5/11/2026, Page 7, Paragraph 1]
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. If the prior art structure is capable of performing the intended use, then it meets the claim. Moreover, with respect to method claims in which an “instruction limitation" (i.e., a limitation "informing" someone about the existence of an inherent property of that method) is added to a method known in the art, the relevant inquiry is whether a new and nonobvious functional relationship with the known method exists. In other words, the ‘informing’ limitation ‘in no way depends on the method, and the method does not depend on the ‘informing’ limitation. MPEP 2112.01(III)
Applicant has not identified any step of the claimed screening method that is performed differently as a result of identifying the compound as a candidate for treating or preventing AMD versus for treating or preventing a mixed infection. The entire “identifying” step is predicated on the same observation made in the prior art, namely, that the test compound inhibits the growth of the population of microorganisms compared to a control. The recited identifying step merely assigns a particular therapeutic application based on the result obtained from the previously recited screening steps. Likewise, Linn discloses performing (a) the culturing step, (b) the measurement step, and (c) determining whether the test compounds (silver nitrate and betadine) inhibit the growth of the population of microorganisms (Pseudomonas Aeruginosa + Staphylococcus aureus) compared to a control. Based on these results, Linn identifies the test compounds as therapeutics for mixed infections, whereas the Applicant identifies the test compound as a therapeutic for AMD. Thus, Linn performs the same screening method and identifies candidate therapeutics based on the same observed result (the inhibition of the growth of the population of microorganisms compared to a control) as the instant claim. Similarly, Belenky discloses performing (a) the culturing step, (b) the measurement step, and (c) determining whether the test compounds inhibit the growth of the population of microorganisms compared to a control. Based on these results, Belenky identifies the test compounds as therapeutics for infections, whereas the Applicant identifies the test compound as a therapeutic for AMD. Thus, Belenky performs the same screening method and identifies candidate therapeutics based on the same observed result (the inhibition of the growth of the population of microorganisms compared to a control) as the instant claim.
Notably, the manner in which the entire screening method performed by Linn and Belenky does not differ from the claimed method. Any distinction arises only after the screening is complete, when a specific therapeutic application is assigned to the results. The limitation “for treating or preventing AMD” does not alter how the screening method is carried out, nor does it create a new or nonobvious functional relationship with the method. On the contrary, it merely assigns a different application or significance to the result observed from performing the screening method.
Applicant asserts the following:
“None of the cited references would have led a person of ordinary skill to expect that inhibiting the growth of the recited microorganism population would identify candidate therapeutics for treating or preventing AMD. In this regard, the Application as filed provides evidence supporting the unexpected results discussed above. The Application as filed explains that the claimed invention is based in part on the unexpected discovery that the intraocular environment is not sterile and that intraocular microbiota can contribute to AMD. Data in the Application as filed further supports that Bacillus megaterium and other microbial species are enriched in the intraocular spaces of AMD patients, that Bacillus megaterium and other enriched microbial species induced various AMD symptoms in animal models, and that the inhibition of such enriched microbial species, in particular, Bacillus megaterium, relieved these AMD symptoms. None of the cited references teach or suggest these results.” [Remarks 5/11/2026, Page 5, Paragraph 5-6 – Page 6, Paragraph 1]
“Further, as similarly discussed above, Applicant submits that a person of ordinary skill in the art still would have found it unexpected that the claimed screening method of this application could identify candidate therapeutics for treating or preventing AMD. Belenky in view of Olstein and Serwer would not have led a person of ordinary skill to expect that inhibiting the growth of the recited microorganism population would identify candidate therapeutics for treating or preventing AMD.” [Remarks 5/11/2026, Page 7, Paragraph 2]
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. The recognition of another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. MPEP 2145(II). Applicant asserts that “none of the cited references would have led a person of ordinary skill to expect that inhibiting the growth of the recited microorganism population would identify candidate therapeutics for treating or preventing AMD,” due to their alleged unexpected discovery. However, the unexpected discovery is directed to a biological relationship between the recited microorganisms and AMD. This alleged discovery merely provides a new rationale for applying the known screening method. In other words, the claimed screening method exists independent of the alleged discovery. Rather than altering the screening method itself, Applicant is merely applying the known screening method to a newly discovered biological relationship. However, the instant rejection is based on whether the claimed screening method would have been obvious to a POSITA, not on whether the biological relationship between the recited microorganisms and AMD was previously recognized. Applicant’s alleged discovery does not require any of the culturing, measuring, or identifying steps recited in the claims to be performed differently, or in a manner not recognized in the art. Ultimately, Applicant is claiming an obvious screening method but limiting the use to identifying candidate therapeutics specifically for AMD. However, doing so does not patentably distinguish the claimed method from an otherwise obvious method.
Applicant asserts “The Office Action relies on Belenky as disclosing a general screening method and states that Belenky discloses that "essentially any bacteria" can be used for determining antibiotic susceptibility or screening candidate antibiotic agents. The Office Action then relies on Olstein for B. megaterium as a pathogenic bacterium. A broad statement in Belenky that essentially any bacteria may be used does not provide a reason to specifically use the recited Bacillus megaterium and/or Pseudomonas putida in combination with the other recited species in the claims of this application.” [Remarks 5/11/2026, Page 6 Paragraph 4-5]
The instant rejection is not based on the arbitrary selection of B. megaterium. Rather, B. megaterium is selected because Olstein identifies it as a pathogenic bacterium of the same class as other pathogenic bacteria already disclosed by Belenky as suitable for use in the screening method. The relevant inquiry is whether the combined teachings of Belenky and Olstein would have suggested including B. megaterium in the population of microorganisms disclosed by Belenky. Belenky discloses that the screening method is applicable to pathogenic bacteria including B. cereus, S. aureus, and S. Epidermidis. Olstein recognizes B. megaterium as a pathogenic bacterium, in conjunction with B. cereus, S. aureus, and S. epidermidis. Accordingly, a POSITA would reasonably have expected that a screening method using pathogenic bacteria, could be extended to include another known pathogenic bacterium, B. megaterium. B. megaterium belongs to the same class of organisms that Belenky contemplates for use in the disclosed method.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILA A CRAIG whose telephone number is (703)756-4540. The examiner can normally be reached Monday-Friday 0800-1600.
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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