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 .
Detailed Action
Claims 51-64 are pending in the instant application.
Election/Restrictions
Applicant elected with traverse SEQ ID NO:35 from List I, E.Coli from list II and bovine from List III in the response filed July 23, 2026.
The restriction is deemed proper and is made FINAL in this office action. Claims 54-55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected
species, there being no allowable generic or linking claim.
Claims 51-53, 56-64 are examined on the merits of this office action.
Claim Objection
Claim 51 is objected for the following informality: the limitation of “SEQ ID NO.: 35: should be replaced with -SEQ ID NO[[.]]:35-.
Claim Rejections - 35 USC § 112
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 52-53, 64 is 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.
Claim 64 recites the limitation “wherein the treatment is an…”; however, there is insufficient antecedent basis for this limitation in claim 51 (from which it depends). Claim 51 recites “a method of treating…” and “thereby treating…..” but does not introduce “a treatment” to provide antecedent basis for “the treatment”. It is therefore unclear what particular “Treatment” is intended by this limitation. A suggested amendment would be “wherein the peptide treats said mastitis by immune-modulation….” Or “wherein administering said peptide provides an immune modulatory treatment of said mastitis….”.
Claim 52 claims “wherein said mastitis is associated with or induced by a bacteria”. The term “associated with” is generally defined as connected with something else. In the instant case, the “associated with” is considered indefinite because the specification fails to provide objective boundaries or definitions for the nature or threshold of the association, leaving the metes and bounds of claim unclear. Claim 53 is also rejected due to its dependence on claim 52 and not further clarifying this point of confusion.
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.
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.
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 51-53, 56-60, 62-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claycomb (WO2020017980, cited in Applicant’s IDS) in view of Haagsman (WO2015170984, cited in Applicant’s IDS), Tomasinsig (INFECTION AND IMMUNITY, Apr. 2010, p. 1781–1788) and Cuperous (Nature, Scientific Reports, 2016, pages 1-11) .
Regarding claim 51, Claycomb teaches of compositions extracted from milk (cationic fractions) comprising bioactive proteins (see Abstract). Claycomb teaches “ In one preferred embodiment the cationic fraction may be extracted from the same species of animal that the treatment substance is intended to be used on. For example a cationic fraction extracted from cow milk to treat/prevent bovine mastitis, or a cationic fraction extracted from goat milk to treat mastitis in goats” (see page 23, third paragraph). Claycomb teaches wherein the cationic fraction comprises CATH-2 (see page 12, paragraph 0005). Claycomb teaches that the emulsion can be used in many different animals including cows, sheep, goats, chickens etc…(see page 35, paragraph 5). Claycomb therefore teaches administering a CATH-2 containing composition to a subject (including cows) to treat or prevent mastitis.
Claycomb is silent to wherein the CATH-2 is SEQ ID NO:35 which is CATH-2 from chicken.`
However, Haagsman teaches of formulations comprising CATH2 derivatives comprising instant SEQ ID NO:35 for use as an antibiotic or medicament for an infectious disease (see claims 7-8 and page 8, lines 11 and page 6, lines 22-25, page 16) and also specific bacteria (claim 43) . Haagsman teaches treatment of E. Coli infections (see 18, second paragraph).
Tomasinsig teaches “Cathelicidins are peptide components of the innate immune system of mammals. Apart from exerting a direct antibiotic activity, they can also trigger specific defense responses in the host” (see abstract). Tomasinsig teaches “Mastitis is an inflammatory process of the mammary gland and is usually a consequence of microbial infection caused by pathogens that find their way into the lumen of the gland through the teat canal” (see page 1781, right column). Tomasinsig teaches “Overall, our studies indicate differential roles for the bovine cathelicidins, regarding both their direct antimicrobial activities and their capacities to activate host cells. The alpha-helical cathelicidins BMAP-27 and -28, in particular, maintain potent antimicrobial activity under mammary inflammatory conditions and may also play roles in activation of the immune response by stimulating the expression of cytokines, such as TNF-α. Bac5 and indolicidin do not appear to modulate the expression of this gene but may trigger other protective responses, such as the reported induction of interleukin 8 (IL-8) by indolicidin and stimulation of cell proliferation by Pro-rich peptides. Furthermore, the simultaneous presence of all the peptides as a result of infection may produce a far more robust response than that of the single molecules. These distinct and complementary functions may contribute to a thorough and sustained response to infection and point to a protective role of cathelicidins in bovine mastitis” (see page 1787, last paragraph).
Cuperus teaches that D-CATH-2 (which comprises instant SEQ ID NO:35) treatment was able to partially protect chickens from E. Coli infection (see abstract). Animals treated in ovo with D-CATH-2 showed an increased total number of leukocytes (p = 0.047) and heterophils (p = 0.004) and prevented E. coli induced lymphopenia (p = 0.0002) (see page 4, paragraph 0002). Cuperus teaches that “Antibiotic resistance is a large and growing problem in both veterinary and human medicine. This has caused an intense search for alternative means to prevent and fight infections. Cathelicidins or derivatives thereof are investigated in areas as diverse as periodontology, skin infections, biofilm related problems and bovine mastitis (see page 2, first paragraph) and show promise as alternatives to antibiotics with the added benefit of inducing little to no resistance.”
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to use the CATH-2 peptide comprising SEQ ID NO:35, as taught by Haagsman and Cuperus, as the CATH-2 peptide in the mastitis treatment or prevention method taught by Claycomb. One of ordinary skill in the art would have been motivated to do so because Claycomb expressly teaches the sue of CATH-2 containing compositions for treating or preventing mastitis; Cuperus teaches the CATH2 peptide comprising SEQ ID NO:35, demonstrates in vivo protection against bacterial infection and suggests applicability to bovine mastitis; while Haagsman identifies the particular CATH-2 peptide comprising SEQ ID NO:35 as a medication useful for infectious disease, including E.coli; and Tomasinsig teaches that the antimicrobial and host defense activities of cathelicidins provide a protective role in bovine mastitis. One of ordinary skill in the art would have had a reasonable expectation of success because the prior art collectively demonstrates that CATH2 was known for treating or preventing mastitis, that the particular peptide comprising SEQ ID NO:35 was known and had demonstrated in vivo protective activity against bacterial infection, including E. Coli, and that cathelicidins were recognized as providing protective antimicrobial and host defense effects relevant to mastitis.
Regarding claims 52-53, the combined references provide motivation to treat bacterial mastitis including E. Coli associated mastitis. As stated in the above paragraph, it would have been obvious to employ the CATH-2 peptide for mastitis associated with E.Coli with a reasonable expectation of success for the reasons discussed above.
Regarding claim 56, As stated above, Claycomb teaches administration of CATH2 for treatment or prevention of mastitis and Tomasinsig further teaches biological activity of cathelicidins under mammary inflammatory conditions and concludes that cathelicidins have a protective role in bovine mastitis. Thus, the prior art therefore teaches or suggests a CATH2 peptide capable of exerting its protective effect in the mammary gland.
Regarding claims 57-58, 64, Tomasinsig teaches that Cathelicidins function not merely through direct antimicrobial activity but also by activating host defense responses including host cell and cytokine responses. Cuperus provides further evidence specific to the claimed peptide, teaching that CATH2 comprising SEQ ID NO:35 results in host immune effects, including increasing leukocytes and heterophils and prevention of E. Coli induced lymphopenia. Nevertheless, these limitations are considered inherent properties of the identical peptide claimed,
Regarding claims 59-60, the claims further recite that the peptide has no antibiotic activity and no direct killing effect on the bacteria. The prior art combination renders obvious administration of the same CATH2 peptide comprising SEQ ID NO:35 in the claimed therapeutic context. Cuperus and Tomasinsig further establish that cathelicidin activity is not limited to direct bacterial killing and includes host directed and immunomodulatory mechanisms, and the prior art recognizes that the biological activity exhibited by such peptides is dependent on the environment in which the peptide acts. The limitations of claims 59-60 characterize properties or results of the peptide under other recited conditions rather than requiring a structurally different peptide or an additional treatment step. The claims do not recite a particular concentration, formulation etc.. or condition that would distinguish the claimed administration from administration of the identical peptide taught or suggested by the prior art combination. Thus, wherein the obvious prior art method results in administration of the identical SEQ ID NO:35 peptide under the conditions encompassed by the claims, the absence of antibiotic activity and or direct bacterial killing that results from the peptide in that environment would be an inherent property of the obvious method. The discovery or recognition of a previously unrecognized property or mechanism resulting from an obvious method, does not, with distinction within the claimed method, render the method nonobvious.
Regarding claim 62, Claycomb specifically teaches treatment of bovine mastitis (see page 23, teachings above).
Regarding claim 53, Claycomb teaches treatment of bovine mastitis, including use of a fraction obtained from cow milk for treating mastitis. Tomasinsig teaches a protective role of cathelicidins in bovine mastitis. It would have been obvious before the effective filing date of the claimed invention to administer CATH2 comprising SEQ ID NO:35 to a dairy cow in carrying out the bovine mastitis treatment. One of ordinary skill in the art would have been motivated to do so because mastitis is a disease in the mammary gland and the references expressly teach CATH2 for treatment of bovine mastitis. Tomasinsig specifically teaches that mastitis is highly prevalent in dairy cow and isolating bacteria from dairy cows with mastitis (see 1782, left column, second to last paragraph).
Claim 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claycomb (WO2020017980) in view of Haagsman (WO2015170984), Tomasinsig (INFECTION AND IMMUNITY, Apr. 2010, p. 1781–1788) and Cuperous (Nature, Scientific Reports, 2016, pages 1-11) as applied to claims 51-53, 56-60, 62-64, in further view of Lippolis (PLoS ONE6(10):e25479.doi:10.1371/journal.pone.0025479).
The combination of Claycomb, Haagsman, Tomasinsig and Cuperus teaches the method of claim 51 as set forth above, but does not teach administration of CATH2 via intramammary injection.
Lippolis teaches treatment of mastitis with intramammary infection with intramammary injection of vitamin D (to the site of bacterial infection) (see abstract, see concluding paragraph).
It would have been obvious before the effective filing date of the claimed invention to administer the CATH2 peptide by the intramammary route as taught by Lippolis for treatment of mastitis. One of ordinary skill in the art would have been motivated to do so because Lippolis teaches intramammary administration as a means of delivering a therapeutic agent directly to the site of bacterial infection when treating mastitis, while Claycomb teaches administration of CATH2 containing compositions for treating or preventing mastitis. One of ordinary skill in the art would have had a reasonable expectation of success because Lippolis demonstrates that therapeutic agents can be administered intramammarily for treatment of mastitis, and the prior art suggests or renders obvious treating mastitis with CATH2 of the instant claims. The use of the known intramammary route to deliver the known CATH2 mastitis therapeutic to the mammary gland would have been a predictable use of a known administration technique for its established purpose.
Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 51-53, 56-64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-69 of copending Application No. 18/719464 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “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” (claim 51). The instant application further claims wherein the mastitis is associated with bacteria (claim 52); wherein the bacteria is e. coli (claim 53); peptide being effective in the mammary gland (claim 56); immune modulatory effects (claim 57 and 64); wherein the subject is a dairy cow (Claims 62-63); intramammary administration (Claim 61).
Co-pending Application claims “a method of activating or inducing innate immune memory in bovine comprising administering SEQ ID NO:35” (claim 55) which is identical to instant SEQ ID NO:35. The instant application further claims wherein the cow has a disease, and wherein it involves E. Coli (see claim 59-60); being effective in the mammary gland (claim 61); immuno modulation (claim 63); intramammary administration (claim 66); dairy cow (claim 68). Co-pending Application doesn’t claim treating/prevention mastitis but does claim intramammary injection and treatment and treating bacteria. Please note that Applicants define “treating” to be inclusive to prevention (see paragraph 0040) and thus, the patient population is not required mastitis. Thus, the patient population of the Co-pending Application over laps with the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/ Primary Examiner, Art Unit 1654
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