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 response filed June 1, 2026, has been received and entered.
Claims 1-4 are pending.
Inherited Case
Examiner Susan Fernandez has inherited the case from Examiner Enosakhare Erhunmwunsee.
Election/Restrictions
Applicant's election with traverse of the species ‘Tetracycline’ for the first round of search and the species ‘Meropenem’ in subsequent searches, in the reply filed on June 1, 2026, is acknowledged. The traversal is on the ground(s) that there would not be a serious search and examination burden if the species election were not required. This is found persuasive; thus, the election of species requirement has been withdrawn.
Claims 1-4 are examined on the merits.
Priority
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 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 disclosures of the prior-filed applications, Application No. 62/487,395, 15/957,780, 16/216,751, 62/924,614, 62/928,815, 62/956,923, 62/977,637, 62/978,149, 62/988,186, and 63/009,337, fail 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. In particular, the prior-filed applications fail to provide support for step (a) of claims 1 and 3 (detect the presence of both E. faecalis and K. pneumoniae in a source of the infection obtained from the patient) and/or step (b) of claim 1 or 3.
Therefore, claims 1-4 have the effective filing date of April 14, 2020 (filing date of Application No. 16/848,651).
Information Disclosure Statement
The information disclosure statement filed September 5, 2024, fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
In particular, a copy of NPL document number 36 (A Foreign Medicine, issue undefined 1999-12-31 Ling Zhiqiang, Rapid Determination of Bacterial Growth Antimicrobial Susceptibility) has not been provided.
Claim Objections
Claims 1-4 are objected to because of the following informalities:
The full names corresponding to the abbreviated terms “E. faecalis” and “K. pneumoniae” are not recited in the claims. The full names (Enterococcus faecalis and Klebsiella pneumoniae) should be recited at the first instances the abbreviated terms appear in the claims (line 2 of claim 1).
Claim 3 is objected to because it recites “K. Pneumoniae” in line 2. The first letter of “Pneumoniae” should be lower-cased. Since claim 3 is objected to, then its dependent claim, claim 4, is objected to.
Appropriate correction is required.
Notice Re: Prior Art Available Under Both Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kotnis-Gaska (Kardiochirurgia I Torakochirurgia Polska. 2018. 15(2): 79-85).
Kotnis-Gaska discloses a case of polymicrobial infection followed by an infection with pandrug-resistant (PDR) Klebsiella pneumoniae in a woman (page 83, left column, last paragraph). Enterococcus faecalis was found in the wound swab of the patient, and additional material from the wound was sent to the laboratory from which Klebsiella pneumoniae with extended-spectrum β-lactamase (ESBL) mechanism was determined after three days (page 83, right column). Therefore, the patient has a polymicrobial infection comprising a combination of E. faecalis and K. pneumoniae, and Kotnis-Gaska teaches detecting the presence of both E. faecalis and K. pneumoniae in a source of the infection (the wound) obtained from the patient, anticipating step (a) of instant claims 1 and 3.
Kotnis-Gaska further states that the patient received multidrug antibiotic therapy comprising meropenem (page 84, left column, first paragraph). Therefore, Kotnis-Gaska discloses administering meropenem to the patient, thus anticipating step (b) of instant claim 1. Since the multidrug antibiotic therapy (linezolid, vancomycin, meropenem, colistin, tobramycin, piperacillin-tazobactam; see page 84, left column, first paragraph) does not comprise amoxicillin/clavulanate or ampicillin/sulbactam, then Kotnis-Gaska discloses administering to the patient an antibiotic other than amoxicillin/clavulanate or ampicillin/sulbactam, anticipating step (b) of instant claim 3. In administering the multidrug antibiotic therapy, then the patient is treated, meeting the preamble of instant claims 1 and 3.
Regarding the limitation “wherein E. faecalis and K. pneumoniae together have a decreased odds of resistance to meropenem and tetracycline, thus meropenem and tetracycline are effective for killing or inhibiting growth of E. faecalis and K. pneumoniae to treat the polymicrobial infection” of instant claim 1 and the limitation “wherein E. faecalis and K. pneumoniae together have an increased odds of resistance to amoxicillin/clavulanate and ampicillin/sulbactam” of instant claim 3: As pointed out in MPEP 2111.04(I), “wherein” clauses are examples of claim language that suggest or makes optional but does not require steps to be performed, thus not limiting claim scope. By using a “wherein” clause, instant claim 1 does not require a step of determining that the E. faecalis and K. pneumoniae together have a decreased odds of resistance to meropenem and tetracycline. Likewise, by using a “wherein” clause, instant claim 3 does not require a step of determining that the E. faecalis and K. pneumoniae together have an increased odds of resistance to amoxicillin/clavulanate and ampicillin/sulbactam. Therefore, these wherein clauses of instant claims 1 and 3 do not limit the claim scope. Moreover, according to MPEP 2112(I), “‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’ Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” Though Kotnis-Gaska does not recognize that the E. faecalis and the K. pneumoniae together have a decreased odds of resistance to meropenem and tetracycline, nor does Kotnis-Gaska recognize that the E. faecalis and the K. pneumoniae together have an increased odds of resistance to amoxicillin/clavulanate and ampicillin/sulbactam, these properties are inherently possessed by E. faecalis and K. pneumoniae when together in an infection. Therefore, Kotnis-Gaska anticipates instant claims 1 (meropenem) and 3.
Claim 3 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin (Internal Medicine. 2012. 51: 1841-1843).
Lin discloses that for a patient, a culture of her peritoneal fluid grew polymicrobial species including Klebsiella pneumoniae and Enterococcus faecalis (page 1842, left column, second-to-last paragraph). Since these two bacterial species were determined, then Lin discloses detecting the presence of both E. faecalis and K. pneumoniae in a source of the infection (the peritoneal fluid) obtained from the patient, anticipating step (a) of instant claim 3.
Furthermore, Lin discloses administering to the patient intraperitoneal antibiotics shifted to cefazolin and ampicillin, with follow-up examination showing a normal functioning peritoneum and a stable peritoneal dialysis course. This is directed to treating the patient, meeting the preamble of instant claim 3. Ampicillin is distinct from ampicillin/sulbactam. Therefore, Lin discloses administering to the patient an antibiotic (each of cefazolin and ampicillin) other than amoxicillin/clavulanate or ampicillin/sulbactam, anticipating step (b) of instant claim 3.
Regarding the limitation “wherein E. faecalis and K. pneumoniae together have an increased odds of resistance to amoxicillin/clavulanate and ampicillin/sulbactam” of instant claim 3: As pointed out in MPEP 2111.04(I), “wherein” clauses are examples of claim language that suggest or makes optional but does not require steps to be performed, thus not limiting claim scope. By using a “wherein” clause, instant claim 3 does not require a step of determining that the E. faecalis and K. pneumoniae together have an increased odds of resistance to amoxicillin/clavulanate and ampicillin/sulbactam. Therefore, this wherein clause of instant claim 3 does not limit the claim scope. Moreover, according to MPEP 2112(I), “‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’ Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” Though Lin does not recognize that the E. faecalis and the K. pneumoniae together have an increased odds of resistance to amoxicillin/clavulanate and ampicillin/sulbactam, these properties are inherently possessed by E. faecalis and K. pneumoniae when together in an infection. Therefore, Lin anticipates instant claim 3.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kotnis-Gaska in view of Bergeron (US 5,994,066. Listed on IDS filed 5/18/26).
As discussed above, Kotnis-Gaska anticipates claims 1 and 3. Kotnis-Gaska differs from claims 2 and 4 in that Kotnis-Gaska does not expressly disclose that E. faecalis and K. pneumoniae are detected in the source of the infection (the wound) without first being isolated.
Bergeron discloses a method for universal detection of bacteria in biological sample and for specific detection of Klebsiella pneumoniae and Enterococcus faecalis in any biological sample (abstract). The method is performed directly on a sample obtained from a human patient (claim 3 of Bergeron). In particular, the method comprises the step of contacting the sample with probes or primers and detecting the presence and/or amount of hybridized probes or amplified products as an indication of the presence of the specific bacterial species (column 4, lines 19-24). Bergeron addresses the need for an advantageous alternative to the conventional culture identification methods to improve the accuracy and the speed diagnosis of bacterial infections (column 3, lines 12-16). DNA-based diagnostic tests are faster and more accurate than standard biochemical tests presently used for diagnosis because the bacterial genotype is more stable than the bacterial phenotype (column 3, lines 16-21).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to detect E. faecalis and K. pneumoniae from the wound swab by the method of Bergeron when performing the method of Kotnis-Gaska. One of ordinary skill in the art would have been motivated to do this because it would have improved the accuracy and speed of diagnosis of the polymicrobial infection of the patient of Kotnis-Gaska. In using the method of Bergeron for detecting the bacteria of the wound swab, then the E. faecalis and K. pneumoniae are detected without first being isolated. Therefore, instant claims 2 and 4 are rendered obvious.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Bergeron (US 5,994,066. Listed on IDS filed 5/18/26).
As discussed above, Lin anticipates claim 3. Lin differs from claim 4 in that Lin does not expressly disclose that E. faecalis and K. pneumoniae are detected in the source of the infection (the peritoneal fluid) without first being isolated.
Bergeron discloses a method for universal detection of bacteria in biological sample and for specific detection of Klebsiella pneumoniae and Enterococcus faecalis in any biological sample (abstract). The method is performed directly on a sample obtained from a human patient (claim 3 of Bergeron). In particular, the method comprises the step of contacting the sample with probes or primers and detecting the presence and/or amount of hybridized probes or amplified products as an indication of the presence of the specific bacterial species (column 4, lines 19-24). Bergeron addresses the need for an advantageous alternative to the conventional culture identification methods to improve the accuracy and the speed diagnosis of bacterial infections (column 3, lines 12-16). DNA-based diagnostic tests are faster and more accurate than standard biochemical tests presently used for diagnosis because the bacterial genotype is more stable than the bacterial phenotype (column 3, lines 16-21).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to detect E. faecalis and K. pneumoniae from the peritoneal fluid by the method of Bergeron when performing the method of Lin. One of ordinary skill in the art would have been motivated to do this because it would have improved the accuracy and speed of diagnosis of the polymicrobial infection of the patient of Lin. In using the method of Bergeron for detecting the bacteria of the peritoneal fluid, then the E. faecalis and K. pneumoniae are detected without first being isolated. Therefore, instant claim 4 is rendered obvious.
Conclusion
No claims are allowed.
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/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
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