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 .
This action is in response to papers filed 6/18/2026.
Applicant’s election without traverse of Group I and LOC108634521 in the reply filed on 9/25/2024 is acknowledged.
Claims 1-2, 4, 6-21 are pending. Claim 3 and 5 are cancelled.
Claims 7-20 are withdrawn as being drawn to a nonelected invention.
The following rejections are maintained with response to arguments following.
This action for claims 1-2 and 4, 6, 21 is FINAL.
Withdrawn Rejections
The 35 USC 112b rejection made in the previous office action is withdrawn based upon amendments to the claims.
CFR 1.132
The declaration under 37 CFR 1.132 filed 6/18/2016 is insufficient to overcome the rejection of claims based upon 35 USC 112a as set forth in the last Office action because: It include(s) statements which amount to an affirmation that the claimed subject matter functions as it was intended to function. This is not relevant to the issue of nonobviousness of the claimed subject matter and provides no objective evidence thereof. See MPEP § 716. See detailed response below.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-2 and 4-6, 21 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn administering antibiotics based upon determining differential expression of LOC1088634521.
Therefore the claims encompass administering based upon expression level however, the specification does not describe administering in any ruminant mammal as compared to a naïve ruminant mammal. In particular the specificiaotn has not limited the definition of “ruminant mammal” in such a way that it would not encompass “nave ruminant mammals”. The specification, however, appears to determine antibiotic treatment in goats infected with mycobacteria and not as claimed any “ruminant mammal”.
The specification discloses in table 1 that host of goat and cow that genes can differentiate infected from naïve animals (p. 15). The table discloses LOC108634521 is upregulated in infected animals versus naïve animals. However, the specification does not provide that any differential expression in any sample from any ruminant mammals functionally detect infection. Furhtermore, as provided below LOC108634521 appears to be derived from goat, however, the specification does not appear to provide support that this structure is observed in cows, rather the table does not indicate that these expression profiles are from both goat and cow or “goat or cow”. Therefore the specification does not provide description of the breath of the claims.
The art (NCBI LOC108634521 downloaded 10/25/2024) teaches that this structures is from goat organism, however, there is no indication that this same structure is found within cow or any other mammal. Further, the art does not provide guidance that expression of LOC108634521 provides that one can treat in any ruminant mammal.
The art does not provide the critical structural elements for the asserted functionality. In particular Enard et al. (Science 2002 Vol 296 p. 340 cited on IDS) teaches that even between closely related species gene expression patterns differ (abstract). Enard et al. teaches that mRNA expression levels are different between humans, chimpanzees, orangutans and rhesus marcques (p. 340 1st column last sentence-2nd column 1st paragraph). Enard et al. teaches that there are a large number of quantitative differences in gene expression in closely related mammals (p. 342 2nd column last paragraph). Therefore the art teaches that even between very closely related mammals there is a divergence of gene expression. As such Enard et al. teaches that merely being a biomarker in one species would not be sufficient to provide support for the structure in other species.
The claims encompass any sample. The art of Cobb et al (Crit Care Med 2002 Vol. 30 p. 2711, newly applied) teaches the unpredictability in analysis of gene expression in spleen and liver sample from septic mice. Notably, the reference teaches that, when compared to a non-septic sample, the relevant expression profiles of the septic mouse spleen and the septic mouse liver contain different nucleic acids at different levels (Table 1; p.2714, middle col., lns.2-8). As such the art teaches that expression levels of the same nucleic acids in different tissue samples differ. Therefore the art indicates that an association of expression level to a disease in one sample would not be described to an association to any other sample type.
Accordingly, the specification has not provided the critical elements needed in the structure to predictive functionally. Therefore the specification lacks written description of any subject representative of the broadly claimed genus.
In analysis of the claims for compliance with the written description requirement of 35 U.S.C. 112, first paragraph, the written description guidelines note regarding genus/species situations that “Satisfactory disclosure of a ``representative number'' depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed.” (See: 'Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.)
Response to Arguments and 37 CFR 1.132
The reply and affidavit traverses the rejection. A summary of the arguments is provided below with response to arguments following.
The reply asserts that the claims no longer encompass a “naïve ruminant” as the subject ruminant (p 7). The reply points to the declaration and asserts expression of homologs of LOC108634521 is found in a representative number of non-goat ruminants (p. 7-8). The reply asserts that goats share a more common ancestor with other ruminants that is stated by the examples in the art (p. 8). The reply asserts that the declaration provides alignments of water buffaloes, domesticated cows to goat in which the homology is closely aligned (p. 8).
The declaration states the homology between goats and cattle and specifically the sequence similarity between LOC108634521 (p. 2-3). The declaration asserts that the main feature of John’s disease are similar in both species (p. 2).
These arguments have been reviewed but have not been found persuasive.
The claims still recite “the subject ruminant mammal”. This term would encompass any type of ruminant mammal including naïve ruminant mammals as there is no indication that naïve requires to not have infections (see para 22). Furthermore, there is no indication that the comparison is a comparison of the same species, but rather can encompass any ruminant type for each.
The claims as amended require antibiotic administration based upon increased expression of LOC108634521 or a homology of 90%. However, the specification has not described these homologies or LOC108634521 in any ruminant animal and the functionality of administering antibiotics. Although the skilled artisan could determine the structure that would represent 90% homology and the structure of LOC1086534521 the specification does not provide that increased expression of these structures are functionally determined in any ruminant species. Furthermore the specification does not describe that increased expression functionally is associated with provided antibiotics. The declaration appears to be providing that the structures are similar in different species and that the phenotypic response to a disease is similar in different species, however, this does not provide that the functionality of expression is correlative between goats and cows. Furhtermore, the declaration does not provide that this functionality is predictably correlated across any of the species encompassed. Therefore the rejection provided above is maintained.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached on 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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