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 is the first action on the merits.
Claims 1-12, 15, 16 and 18 are pending and under consideration.
Information Disclosure Statement
The applicant has an obligation to call the most pertinent prior art to the attention of the U.S. Patent and Trademark Office in a proper fashion. Burying one reference in one hundred other IDS references is like citing nothing. PENN YAN BOATS, INC. v. SEA LARK BOATS, INC. 175 USPQ 260 (S.D. Fla. 1972). Golden Valley Microwave Foods, Inc. v. Weaver Popcorn Co. Inc., 24 USPQ2d 1801 (U.S. Dist. N. Dist. IN 1992).
Claim Objections
Claims 2 and 3 are objected to because of the following informalities: the phrase "the presence or absence of a bond" should be replaced with "presence or absence of an additional bond", see under the line under the definition of R⁴. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the [fifth paragraph of 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Said claim does further limit claim 1 based on the definition of R4. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 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(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-12, 15, 16 and 18 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Yoshida et al. (US 8188271).
The present claims embrace the following species:
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.
The reference teaches the following species:
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, see column 71, compound number 6. The composition is taught in column 8, (18) and column 1, lines 25-32. The compounds in the ‘271 patent are racemic mixtures and therefore embrace all diastereomers. This is just one example in the reference. However, the ‘271 patent is replete with species which render obvious at least claim 1 of the present application.
The only differences between these species are 1) the stereochemistry noted at the fused ring bond of the piperidine ring of the presently claimed species; and 2) the methyl group substituted on the cited species from the ‘271 patent.
The cited species does not indicate the stereochemistry at the fused ring bond of the piperidine ring and therefore is a racemic mixture. Thus, all diastereomers are found in the racemic mixture. Moreover, it is well-known in the art, that isolated stereoisomers can be more potent or active than other stereoisomers. Thus, one of ordinary skill in the art would have been motivated to select any of the different possible configurations of the compounds of formula (I-A) with the expectation that the compounds would possess similar activities. Applicants are requested to note that MPEP § 2144.09 teaches that stereoisomers are prima facie obvious. See also In re May, 574 f.2d 1082, 197 USPQ 601 (CCPA 1978).
The second difference is H versus a methyl group. Since a methyl group is considered a homolog of hydrogen these compounds are considered equivalent. The 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 1977).
Both the cited reference and the present application have the same utility.
Therefore, said claims are rendered obvious by Yoshida et al.
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 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 1-12, 15, 16 and 18 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2 and 4-14 of U.S. Patent No. 8188271. Although the conflicting claims are not identical, they are not patentably distinct from each other because for the same reasons provided in the art rejection above.
Claims 1-12, 15, 16 and 18 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11649236. Although the conflicting claims are not identical, they are not patentably distinct from each other because the species found in claims 1 of the ‘236 patent are embraced by the present genus.
Claims 1-12, 15, 16 and 18 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12139489. Although the conflicting claims are not identical, they are not patentably distinct from each other because the species found in claims 1 of the ‘489 patent are embraced by the present genus. The claims in the ‘489 patent are drawn to a method of treating an HIV infection. There is patentable distinction between compounds and methods of use of said compounds.
Claims 1-12, 15, 16 and 18 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12564595. Although the conflicting claims are not identical, they are not patentably distinct from each other because many of the species found in claims 1 of the ‘595 patent, e.g. the species shown below, which is compound A, are embraced by the present genus.
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The claims in the ‘595 patent are drawn to a composition that comprises compound A and compound B, a compound having anti-HIV activity. It has been held that combinations of two or more compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is to be used for the very same purpose. In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). Thus, it would have been obvious to combine the compounds A and B with the expectation that such a combination would be effective in treating HIV. Therefore, combining them flows logically from their having been individually taught in prior art with the same utility.
Claims 1-12, 15, 16 and 18 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 17-28 of copending Application No. 19458062. Although the conflicting claims are not identical, they are not patentably distinct from each other because many of the species found in claims 1 of the ‘062 application patent, e.g. the species shown below, which is compound A, are embraced by the present genus.
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The claims in the ‘062 application are drawn to a composition that comprises compound A and compound B, a compound having anti-HIV activity. It has been held that combinations of two or more compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is to be used for the very same purpose. In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). Thus, it would have been obvious to combine the compounds A and B with the expectation that such a combination would be effective in treating HIV. Therefore, combining them flows logically from their having been individually taught in prior art with the same utility.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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