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 .
Claim Status
Claims 1-5 are pending. Claims 1-5 are rejected.
Drawings
Drawings have been considered and accepted by examiner.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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
Claims 1-5 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 some scope of the word ‘treating’, specifically to heal, alleviate, relieve, alter, improve, or affect COPD in a subject, does not reasonably provide enablement for the whole scope of treating COPD in a subject as claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. As the applicant states:
The term "treat," "treating" or "treatment" as used herein refers to the application or administration of a composition including one or more active agents to a subject afflicted with a disease, a symptom or conditions of the disease, or a progression of the disease, with the purpose to cure, heal, alleviate, relieve, alter, remedy, ameliorate, improve, or affect the disease, the symptoms or conditions of the disease, the disabilities induced by the disease, or the progression of the disease. [0036]
However, SP-D and its recombinant fragments cannot fulfill the whole scope of the word ‘treating’ laid down by the applicant’s specifications. Currently, the state of the prior art provides enablement for clearing necrotic and apoptotic cells in a patient with COPD by administering recombinant Surfactant Protein D polypeptides (US8865643B2; see claims 1 and 2). The current state of the prior art does not provide support for the enablement to cure, remedy, or ameliorate COPD. As NHS states, there is currently, no cure for COPD. Treatment can only slow the progression of the disease and control the symptoms [pgh 1].
Treatment - Chronic Obstructive Pulmonary Disease (COPD). (2023, April 11). NHS. Thus, there exists a lack of predictability that the SP-D and its recombinant fragments can cure, remedy, or ameliorate COPD. The inventors provide direction by showing alleviated lung function and inflammation, decreased ROS production and early-stage apoptotic cells, and affecting oxidative stress-related genes [0019-0027]. The inventors provided examples of experimentation in Figures 1-12. There would be a need for undue experimentation to use the invention to cure COPD. Thus, the specifications and prior art supports enablement to heal, alleviate, relieve, alter, improve, or affect COPD,
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 2 and 3 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “native” in claims 2 and 3 is a relative term which renders the claim indefinite. The term “native” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the specifications, one example of ‘native’ SP-D is that consisting of SEQ ID NO: 1 [0010]. However, a specific definition is not given and one of ordinary skill in the art cannot assign one well known definition. For example, native can mean a properly 3D-folded state of the protein or it can mean using a sequence native to the subject which it is being administered to. Thus, claims 2 and 3 are rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 102
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.
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, 4 and 5 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Clark et al. (US Patent US8865643B2; Published 2014).
Clark et al. teaches recombinant polypeptide SP-D compositions to treat inflammatory diseases [Summary, Pgh 1]. Of the compositions, Clark et al. teaches a method for clearing necrotic and apoptic cells using a recombinant SP-D peptide [SEQ ID NO:1] to patients suffering from lung diseases such as COPD [see claims 1-3]. Clark et al. anticipates using a recombinant fragment of SP-D, such as applicant’s SEQ ID NO:2, to treat COPD because applicant’s SEQ ID NO:2 is the same as Clark et al’s SEQ ID NO:1 and Clark et al is administering the peptide to the same patient population, so it would inherently result in the applicant’s method of treating COPD [see MPEP 2112].
Claim Rejections - 35 USC § 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 (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.
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.
Claims 2 and 3 are rejected under 35 USC 103 as being unpatentable over Clark et al. (US Patent US8865643B2; Published 2014) as applied to claim 1 above, and in further view of McCormack et al (US Publication: US20040037781A1, Published 2004.
The teachings of Clark et al. are discussed above with regard to claim 1. Clark et al. further teach rSPD(n/CRD) may also be used as an effective treatment for conditions that would benefit from the up-regulation of the cell-mediated immune system. This includes anti-microbial action and the treatment of lung infections [Col 7, Pgh 8]. However, Clark et al. do not expressly teach administering human surfactant D protein
McCormack et al. teaches that full length humans SP-D and SP-A protein and peptides derived from them possess antimicrobial properties and can be used to decrease lung injury due to hyperoxia, inflammation or infection [0014]
It would have been obvious prior the effective filing date of the claimed invention to substitute human SP-D taught by McCormack et al. for the rSPD(n/CRD) of Clark et al. The artisan of ordinary skill would have been motivated to make the substitution because human SP-D is antimicrobial like rSPD(n/CRD). There would be a reasonable expectation of success because the artisan would be substituting equivalent proteins for the same purpose [see MPEP 2144.06].
Claims 1-3 are also rejected under 35 U.S.C. 103 as being unpatentable over McCormack et al (US Publication: US20040037781A1, Published 2004) in view of Barnes P. J. (2020). Oxidative stress-based therapeutics in COPD. Redox biology, 33, 101544.
McCormack et al. teaches a method of treating conditions associated with the oxidation of lipids and other molecules and microbial proliferation by administering an antimicrobial lung surfactant protein compound [Abstract]. Of the surfactant proteins, SEQ ID NO:9 consists of applicant’s amino acid sequence of SEQ ID NO:1 [claims 3 and 4]. McCormick does not teach the link between oxidative lung injury and COPD. Barnes teaches that treating oxidative stress by antioxidants or enhancing endogenous antioxidants should be an effective strategy to treat the underlying pathogenetic mechanisms of COPD [Abstract]. This is because the “lung tissue from COPD patients shows increased lipid peroxidation, as measured by 4-hydroxy-2-nonenal (4HNE), which reflects an effect of ROS on endogenous lipids” [section 2].
Therefore, McCormack et al and Barnes provides sufficient motivation before the effective filing date to administer human SP-D to treat COPD because Barnes teaches that lipid peroxidation and oxidative stress are associated and with COPD and McCormack et al teaches human SP-D can be used to treat conditions associated with lipid oxidation. It would have been obvious to one of ordinary skill in the art to combine the teachings with reasonable expectation of success.
Summary
Claims 1-5 are rejected under 35 U.S.C. 112(a). Claims 2 and 3 are rejected under 35 U.S.C. 112(b). Claims 1, 4 and 5 are rejected under 35 U.S.C. 102. Claims 1-3 are rejected under 35 U.S.C. 103.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SACHI JAUHARI whose telephone number is (571)272-3769. The examiner can normally be reached Mon-Fri 9-4.
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/SACHI JAUHARI/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654