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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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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 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 of this title, 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 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 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.
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 55-69 are rejected under 35 U.S.C. 103 as being unpatentable over Haagsman (US2017/0145065A1).
For claim 55:
Haagsman teaches a method for activating the immune response of an animal or human comprising providing said animal or human with a CMAP27 derivative, wherein said CMAP27 derivative is selected from the group of C-terminally truncated CMAP27 derivatives, N-terminally truncated CMAP27 derivatives, D-amino acid CMAP27-derivatives, cyclic CMAP27-derivatives, inverso and retroinverso CMAP27-derivatives, wherein the activation of the immune response is chosen from enhanced Toll-like receptor activation by increased DNA uptake, endotoxin neutralization, stimulation of cytokine/chemokine production by immune cells, direct chemotaxis, enhanced phagocytosis and stimulation of the proliferation and differentiation of immune cells. [see claims 4-5], wherein N-terminally truncated CMAP27 derivative is CMAP1-21 and its D-form is RFGRFLRKIRRFRPKVTITIQ-NH2 [see 0027-0029], wherein CMAP proteins are also indicate as CATH2 peptides, and CMAP21 would be CATH2(1-21) [see 0027].
In the above sequences of CMAP1-21 [aka CATH2(1-21)] is identical to applicants SEQ ID NO:35.
Haagsman defines animals other than humans, as cattle or domestic animals [see 0052].
Difference is that Haagsman is silent on exemplifying their method in bovine in their disclosure.
However, ‘bovine’ is included in the definition of ‘animals’, specifically ‘cattle’, in the teachings of Haagsman. Based on the guidance and exemplified data in the Haagsman, a skilled person in the art can extrapolate the same method to bovine and arrive at applicants method with a reasonable expectation of success. Therefore, claim is obvious over the art.
For claims 56-58:
In the teachings of Haagsman, the purpose of administering CMAP27 derivative is to activate immune response or boost their innate immune system [see 0066].
So, the above is interpreted as bovine lacks ability to activate innate immune memory, and once it is activated, which enhances release of Toll-like receptor activation by increased DNA uptake, endotoxin neutralization, stimulation of cytokine/chemokine production by immune cells, direct chemotaxis, enhanced phagocytosis [see above in For claim 55], and these act against a pathogen.
For claims 59-60:
Haagsman teaches that their peptides show protection against E.coli [see Fig.4-7 and 9; 0034, 0063; Examples 2 and 4].
For claims 61-65:
These are the properties of the peptide. Since the peptide is identical to the peptide of prior art, these properties are expected.
For claim 66:
Haagsman teach that direct delivery of the peptide compositions will generally be accomplished by topical application or other forms of administration, either orally, parenterally, subcutaneously, sublingually, intralesionally, intraperitoneally, intravenously or intramuscularly, pulmonarily, or delivered to the interstitial space of a tissue. [see 0042 and 0050], which reads intra-mammary administration.
For claim 67-68:
See For claim 55 above.
For claim 69:
Since the peptides activate immunity, and so, the method of Haagsman interpreted as immune-modulatory treatment.
In addition, Haagsman also teaches that the effectiveness of the compounds of the present invention is not only provided by their antibiotic effect, but also by their immunomodulatory effects. Further, the newly discovered immunoactivating effects provide a further advantage of the present compounds. [see 0064 and 0069].
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants CATH2 and its properties etc., were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
Modification of prior art is only proper if a person of ordinary skill in the art at the time of the invention, faced with the same problem, would have been motivated to modify their teachings with a reasonable expectation of success. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Here, the technical fields and problems addressed by the references are not distinct from that of the present invention.
So, the motivation to modify the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed method with a reasonable expectation of success.
Nonstatutory Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 55-69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US copending application # 18/294,706.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Instant claims are drawn to a method for activating or inducing innate immune memory in a bovine in need thereof, the method comprising: administering to said bovine an effective amount of cathelicidin 2 (CATH2) peptide, wherein said peptide comprises the amino acid sequence set forth in SEQ ID NO.: 35, 36, or 37, thereby activating or inducing innate immune memory in said bovine. Dependent claims define the effect of activating innate immunity as protecting against pathogen, such as E.coli, S.aures, S.uberis or combination thereof.
Claims of copending application are drawn to a method for treating a mastitis in a subject, the method comprising: administering to said subject cathelicidin 2 (CATH2) peptide, wherein said peptide comprises the amino acid sequence set forth in SEQ ID NO.: 35, 36, or 37, thereby treating said mastitis in said subject. Dependent claims define bacteria associated with mastitis, properties of the peptide and the treatment is immune-modulatory treatment etc.
In both cases peptides are identical and their effects are identical. Further, The method of instant claims can also be interpreted as method of treating bacterial infection in bovine, since the effect of activating immunity is nothing but treating bacterial infection.
The difference, however, does not constitute a patentable distinct, because of overlap of the scope of subject matter and their end property, and therefore obvious.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not been patented yet.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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