DETAILED ACTION
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 .
Amended claims 1, 5, (4/24/2026), are pending and under consideration by the Examiner.
Claims 2-4, and 6-9 have been canceled.
3. Receipt of Applicant's arguments and amendments filed on 4/24/2026 is acknowledged.
4. The following previous rejections and objections are withdrawn in light of applicants amendments filed on 4/24/2026:
(i) the rejection of claims 1-5 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement;
(ii) the rejection of claims 1-5 are under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph; Applicant's arguments with respect to the above claims have been considered but are moot in view of the new grounds of rejection over claims 1, and 5;
(iii) the rejection of claims 1-2 under 35 U.S.C. 103 as being unpatentable over Malhotra et al (2006) in view of Rahman et al (2019) and Soemarwoto et al (2019);
(iv) the rejection of claims 1-4 under 35 U.S.C. 103 as being unpatentable over Malhotra et al (2006) in view of Rahman et al (2019) and Soemarwoto et al (2019) and further in view of US 2019/0008939 A1 (‘939); and
(v) the rejection of claims 1-2, 5 under 35 U.S.C. 103 as being unpatentable over Malhotra et al (2006) in view of Rahman et al (2019) and Soemarwoto et al (2019) and further in view of US 2019/0367561 A1 (‘561).
Claim Rejections - 35 U.S.C. § 112(b)
5. 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.
5a. Claims 1 and 5 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.
Claims 1, line 5, is improper because the name of the bacterium “Neisseria meningitidis” should be italicized. This follows the standard convention where both the genus and species names are italicized to distinguish them from common names or other text.
Claim 5 is rejected as vague and indefinite insofar as it depends on the above rejected claim 5 for its limitations.
Claim rejections-35 U.S.C. 103
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 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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
6a. Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Malhotra et al (2006) in view of Rahman et al (2019) and Soemarwoto et al (2019), and further in view of Gonzalez et al (2000).
Claim 1 is drawn to method of treating a subject afflicted with a chronic obstructive
pulmonary disease comprising administering to the subject an effective amount of a vaccine composition, wherein said vaccine composition comprises carrier protein conjugated to a recombinant human EGF, and wherein the carrier protein is P64k from Neisseria meningitidis. Dependent claim 5 recites that the vaccine composition administered in the claimed method, additionally comprises an adjuvant that is selected from the group consisting of incomplete Freund's adjuvant, particulate proteic adjuvants, and liposomes.
Malhotra et al (2006) discloses emerging drugs for the treatment of COPD (chronic obstructive pulmonary disease), and that airway mucus hypersecretion is a common feature of COPD and that EGFR is implicated in this process (See Section 4.3 on page 278, right column). The involvement of EGFR activation in the generation of abundant mucus in the airways of COPD patients is also disclosed (See Section 4.4, page 279, left column). On page 285, Table 6, one of the novel mucolytic medications to be used for COPD is disclosed to be Gefitinib, an EGFR inhibitor. On page 286, left column, last paragraph (Section 5.15.3), the reference discloses that Gefitinib, an inhibitor of EGFR, may be able to modify the deleterious effects of mucus hypersecretion in cancer patients and states that whether this can be effectively extrapolated to COPD patients remains to be seen. In view of the possible severe adverse events of Gefitinib the reference suggested that newer generations of EGFR blockers or tyrosine kinase modifiers may have fewer side effects with increased efficacy in modulating mucus secretion in COPD. The reference is silent with respect to a method of administering an EGF-depleting immunotherapeutic agent to treat COPD.
Rahman et al (2019) discloses that neutrophilic inflammation is central in COPD (See page 1, last paragraph). The reference further discloses that drugs that inhibit ErbB kinases (which are structurally related to EGFR) help to reduce inflammation by promoting death of neutrophils and since these drugs are used to treat cancer, the reference discloses that it may be possible to repurpose these drugs to treat COPD (See page 2, 5th paragraph).
Soemarwoto et al (2019) discloses that chronic mucus hypersecretion is a common feature in COPD and is associated with EGF activity (See abstract, first line of the background section). The reference concludes that the plasma levels of EGF may contribute to the pathogenesis of COPD (See last line of the abstract). The reference further discloses that highly elevated circulating levels of EGF are found in serum samples of COPD patients (See section bridging pages 24 and 25).
The references are silent with respect to a method comprising administering a vaccine composition comprising recombinant human EGF conjugated to a carrier protein wherein the carrier protein is P64k from Neisseria meningitidis.
Gonzalez et al (2000) teaches that conjugating a peptide to the P64k meningococcal protein from Neisseria meningitidis, and administering the peptide conjugate to mice, resulted in a murine humoral immune response that was higher in the mice immunized with the conjugated peptide than in those receiving the free peptide, and as a carrier the P64k was higher at stimulating a humoral immune response than well-established carriers bovine serum albumin (BSA) and tetanus toxoid (TT) because of the foreignness of the P64k which contributed to its performance in this respect. Furthermore, P64k has been shown to be safe and immunogenic after a three-dose immunization protocol (See abstract; page 115, Figures 2-3; page 115, column 2, last paragraph; page 116, column 1, lines 1-12).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the instant invention was conceived, to modify the method of Malhotra et al and administer an agent that inhibits EGF (which EGF stimulates EGFR), to treat COPD in view of the combined teachings of Rahman et al and Soemarwoto et al, which establishes a link between higher expression of EGF in COPD and provides the motivation to a person skilled in the art to inhibit EGFR signaling by depleting EGF with an EGF-depleting immunotherapeutic agent, such as a vaccine composition that induces the production of EGF specific antibodies, with an expectation of success. It would have been obvious to one of ordinary skill in the art, at the time the instant invention was conceived, to modify the method as disclosed by Malhotra et al (2006) in view of Rahman et al (2019) and Soemarwoto et al (2019) and conjugate the low molecular weight EGF protein (53 amino acids) to a carrier protein, such as P64k, to increase its immunogenicity as disclosed by Gonzalez which provides the motivation and expectation of success to conjugate EGF with P64k.
Therefore, the combination of references renders obvious claims 1, 5 in the absence of evidence to the contrary.
Applicant argues that claim 1 has been amended to specify that the carrier protein is P64k from Neisseria meningitidis, and that as demonstrated in the examples set forth in the specification, Applicant has demonstrated unexpectedly good results by administering a vaccine composition that includes the carrier protein P64k from Neisseria meningitidis conjugated to a recombinant human EGF. However, contrary to Applicant’s arguments, the Examiner has recited a new 35 USC 103 rejection based on a combination of references encompassing human EGF conjugated to the carrier protein P64k from Neisseria meningitidis.
6b. Claims 1, 5 are rejected under 35 U.S.C. 103 as being unpatentable over Malhotra et al (2006) in view of Rahman et al (2019) and Soemarwoto et al (2019) and further in view of Gonzalez et al (2000) and US 2019/0367561 A1 (‘561).
The teachings of Malhotra et al (2006), Rahman et al (2019) Soemarwoto et al (2019), and Gonzalez et al (2000), are set forth above in paragraph 6a. The references are silent with respect to a method of administering an EGF vaccine composition comprising an adjuvant.
‘561 discloses that adjuvants such as incomplete Freund’s adjuvant, oil adjuvants (emulsifiers) such as liquid paraffin (mineral origin), cod liver oil (animal origin), and olive oil (plant origin), are convenient, readily available and commonly used to enhance the protective efficacy and enhance the immune response to a vaccine by creating a water-in-oil emulsion to act as a "depot" that slowly releases the antigen at the injection site, boosting the immune response due to the slow release which creates a sustained exposure to the antigen and promotes a longer-lasting and higher antibody response compared to an antigen alone (See [257-258]).
It would have been obvious to one of ordinary skill in the art, at the time the instant invention was conceived, to modify the method as disclosed by Malhotra et al (2006) in view of Rahman et al (2019), Soemarwoto et al (2019), and Gonzalez et al (2000), and add an adjuvant like incomplete Freund’s adjuvant to the vaccine composition to enhance the protective efficacy of the vaccine as disclosed by ‘561 which provides the motivation and expectation of success to add adjuvants to vaccine compositions.
Therefore, the combination of references renders obvious claims 1, and 5 in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Claims 1, and 5 are rejected.
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.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PREMA MARIA MERTZ whose telephone number is (571)272-0876. The examiner can normally be reached on Monday to Thursday from 7:30am to 6:00pm.
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1674
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