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 .
Status of the application
Receipt of applicant’s remarks filed on 12th June 2026 are acknowledged.
However, applicants arguments are found not persuasive, and accordingly, previous 103 rejection is maintained.
Response to Arguments
With regard to applicants arguments under 1) Technical and Structural Differences Between the Claimed Invention and Pitzalis…
Claims are drawn to a product and the product should be compared to the product of prior art. In this case, Pitzalis teaches monomeric unit, which is SPS, where as claims require at least dimeric unit. Advantages of dimeric or higher show superior properties over the monomeric units as evidenced from the cited Marianayagam and Cochran.
Even if applicants incorporate the property of the product in the claims, still is obvious based on the following case laws:
The cited property in the arguments for the claimed product is expected in the product of Ptizalis. A compound and all of its properties are generally inseparable. In re Papsech, 315 F2d. 381, 137 USPQ 43, (CCPA 1963). The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
With regard to applicants arguments under 2) Lack of Motivation to Combine Pitzalis with Marianayagam and Cochran…
Applicants show how each cited reference differ from the instant invention, but the obviousness test under 35 U.S.C. 103 is whether the invention would have been obvious in view of the prior art taken as a whole. In re Metcalf et al. 157 U.S.P.Q. 423.
Applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, all the art rejections are under 35 USC 103, which relies on the combination of the references together.
In this case, both Marianayagam and Cochran teach advantages of dimer and higher oligomeric peptides over their monomeric units. The point of interest is on the properties of monomer vs dimer etc. So, based on established evidences a skilled person in the art would be motivated to utilize the teachings of cited art and extrapolate the same to dimer or higher units.
With regard to applicants arguments under 3) Failure to Meet the Requirements for Applying the Doctrine of Adjacent Homologs…
Based on established case law, the -CH2- is interpreted as a single repeating unit and same logic can be applied to applicants dimer and higher oligo peptides. The logic and reasoning comes from the repeating units in the multimer and this can be applied to divergent chemical groups.
With regard to applicants arguments under 4) Unexpected and Significant Results of the Claimed Invention…
Shown data is nothing but property of the dimer, and which is expected. It is not clear why the shown data is unexpected? Is it unexpected to monomer or something else? No comparative data is shown.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Pitzalis (US 2005/0100555 A1) in view of Marianayagam (TRENDS in Biochemical Sciences, vol.29, No.11, Nov 2004, 618-625), Cochran (Immunity, March 2000, vol.12, 241-250) and Isidro-Llobet (Chem.Rev., 2009, 109, 2455-2504).
Pitzalis teaches a sequence SPS for use for the treatment of inflammatory arthritides and [see claim 37 and 44].
Differences between Pitzalis and instant claim are as follows:
(i) Pitzalis silent on applicants claimed limitation, where n=2-10.
(ii) Pitzalis silent protecting group on N- or C-terminus of the peptide.
With regard to (i) of above, MPEP 2144.09 states “Compounds which are….homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by –CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA).
Adjacent homologs are considered to be obvious absent unexpected results. In re Henze, 85 USPQ 261, 263, CCPA 1950. Also explore MPEP 2144.09.
In this case, the SPS is single chemical group (like -CH2- group in the case law) and its successive repeating units are interpreted as adjacent homologs. According to above case law(s), applicants claim is obvious over the teachings of Pitzalis.
In addition to above, dimer or higher oligomers have advantage over its monomeric units. For example, Marianayagam teaches advantages of dimer and higher oligomeric peptides over their monomeric units [see Concluding remarks in page 624]. Cochran teaches also teaches that dimer and higher oligomeric peptides show advantages over their monomeric units [see abstract and Concluding part in 3rd paragraph in left column in page 248].
Therefore, a skilled person in the art would be motivated to prefer dimeric or higher multimer in view of their advantages over monomeric form.
With regard to (ii) of above, N- and C-terminus protecting groups are well known in the art. For example, Isidro-Llobet teaches N- and C-terminus protecting groups [see Table 2 and section 4]. A skilled person in the art would prefer protecting reactive groups of peptide and so, N- or C-terminus protecting groups are obvious over its unprotected peptide.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components, such as monomeric units and protecting groups 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.
The motivation to combine 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.
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
Conclusion
THIS ACTION IS MADE FINAL. 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 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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