DETAILED CORRESPONDENCE
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 the papers filed February 20, 2026. Currently, claims 1, 3-11 are pending.
All arguments have been thoroughly reviewed but are deemed non-persuasive for the reasons which follow.
Any objections and rejections not reiterated below are hereby withdrawn.
The new matter rejection has been withdrawn in view of the support in paragraph 18 and 28.
Priority
This application is a divisional of 15/781,644, filed June 5, 2018 which is a 371 of PCT/JP2017/021040 filed June 7, 2017 and claims priority to PCT/JP2016/070343, filed July 8, 2016.
It is noted that the PCT/JP2016/070343 has not been translated.
Drawings
The drawings are acceptable.
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.
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 1, 3-11 are rejected under 35 U.S.C. 103 as being unpatentable over Pressure Biosciences Inc. (PBI) Application Note, Detection of Propionibacterium acnes 16S rRNA and Lipase Genes from Sebum Samples Collected on Lipid-specific Adhesive Skin Strips and Processed by Pressure Cycling Technology (PCT) - 10/04/09; 2009; p 1-2 (retrieved from https://www.pressurebiosciences.com/news/publications-by-type/archived-publications-and-posters/an-1006-v1-detection-of-propionibacterium-acnes-16s-rrna-and-lipase-genes-from-sebum-samples-collected-on-lipid-specific-adhesive-skin-strips-and-processed-by-pressure-cycling-technology-pct-10-04-09, retrieved on 10/28/2021), in view of Shetage et al. (Skin Res Technol. Vol. 20, No. 1, pages 97-107, 2014).
PBI teaches detection of P. acnes bacteria 16S rRNA from sebum samples (secretions secreted from a sebaceous gland). PBI teaches sebum samples were collected using commercially available lipid-specific pore-cleansing adhesive skin strips. The samples were from the forehead or neck (page 1, para 3)(limitations of Claims 2, 8). PBI teaches processing the skin lipid absorbent material and purified RNA from the strips. RNA was extracted and pelleted for further analysis (limitations of Claim 4, 5). PBI teaches the products analyzed were 946, 746 and 515bp in length (limitations of Claim 3).
PBI does not teach using an absorbent material that is used in a dry state but is not an adhesive material.
Shetage teaches previous studies have collected sebum or skin surface lipids using cigarette paper. Shetage teaches each medium was cut in to squares, soaked in diethyl ether and fully dried before use (limitations of Claim 6). The medium was applied to five sites on the forehead of the volunteer. Shetage teaches the cigarette paper was ideal. Shetage teaches cigarette paper is a suitable collection medium for sebum (Table 3). Shetage teaches the paper was held in place with an elasticated head band for 3 hours.
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention to have substituted the sebum collection films used for RNA analysis taught by PBI with the dry state skin lipid absorbent material. Shetage teaches collecting skin samples comprising sebum and skin surface lipids using dry state absorbent material. The prior art compares different collection methods and teaches the equivalence of the collection methods, such that the ordinary artisan would have been motivated to have substituted the pore-cleansing adhesive skin strips in PBI with cigarette paper or cotton swabs. The ordinary artisan would have been motivated to have collected sebum on the sebum collection device to allow detection of rRNA from the sebum. There would have been a reasonable expectation of success that the sebum oils could be extracted from the dry state skin lipid absorbent materials of Shetage.
Response to Arguments
The response traverses the rejection.
The response argues Shetage does not teach using an elasticated headband to hold cigarette paper in place involves rubbing. Shetage teaches the cigarette paper is attached to the forehead with an elasticated headband for 3 hours and the ordinary artisan would not conclude that a 3 hour, pressurized attachment of the cigarette paper is important to ensure adequate collection of RSSC. This argument has been reviewed but is not persuasive. The claim requires “rubbing the skin surface with a surface skin lipid absorbent material”. Shetage teaches using an elasticated headband to hold cigarette paper in place for collecting RSSC. The use of an elasticated headband to hold paper in place would necessarily include rubbing. The mere placement of the headband on the paper would invoke rubbing. The continual contact between the paper and the headband would cause friction between the skin and the paper that would constitute rubbing of the paper on the skin.
The response argues “Rub” is defined by Googles English dictionary are to move one’s hand or a cloth repeatedly back and forth on the surface of something with firm pressure. The specification does not provide any particular definition of rubbing. The Merriam-Webster definition provides multiple definitions including “to fret or chafe with or as if with friction”. Dictionary.com also provides rubbing is “to move (two things) with pressure and friction over or back and forth over each other. None of these definitions would exclude using an elastic headband to rub the paper on the forehead. Thus, Shetage teaches rubbing the paper on the forehead.
The response asserts that one of ordinary skill in the art would have understood that Shetage’s cigarette paper, “which is immobilized and held “in place’ with an elasticated headband, does not involve moving the SSL absorbent material back and forth by rubbing. This argument has been reviewed but is not persuasive because to affixed a cigarette paper on a forehead with an elasticated head band would require rubbing. The affixing of the paper with an elasticated headband would require moving the paper and the headband into place which inherently includes rubbing.
The response asserts the present inventors unexpectedly discovered that a much easier collection method using rubbing is able to achieve successful collection of human RNA and this results rebuts any possible case of obviousness. This argument has been reviewed but the response has provided no evidence of the unexpected result. Thus the argument is not persuasive.
The response and the Declaration argue that one of ordinary skill in the art, reading PBI and Shetage would not have any reason or motivation to use cigarette paper used in Shetage in the PBI method to detect nucleic acids using paper wiped on skin. The response and the Declaration cite George to demonstrates P. acnes is an anaerobic bacterium that grown and has activity in the absence of oxygen. Further, Evans is cited to state P. acnes is found in pores rather than on the skin. This argument has been reviewed but is not persuasive. PBI teaches sebum collected from facial skin comprises 16S rRNA and Lipase genes. Shetage teaches collecting sebum from the forehead by wiping cigarette paper on the skin, a dry, non-adhesive material. While the response and Declaration suggest nucleic acids of P. acnes is only found from material “within” pores, this assertion is not supported by the state of the art. This interpretation of the state of the art and how the skilled artisan would have interpreted PBI and Shetage is directly contradicted by Alexeyev et al. (Anaerobe, Vol. 18, pages 479-483, 2012) and Omer et al. (Clinics in Dermatology, Vol. 35, pages 118-129, March -April 2017), who demonstrate that before PBI and Shetage, the art understood that P. acnes could be detected using a swab from the superficial stratum corenum (i.e. the outermost layer of skin) (see Table 1). Omer specifically states that the swab technique refers to surface sampling using a sterile tissue to brush the skin which is noninvasive and cheap and can be applied to the sampling of many patients in a short period. Thus, the state of the art demonstrates that swabbing using cigarette paper on the skin would collect P. acnes that would allow the acne causing bacteria detection. Thus, for the reasons above and those already of record, the rejection is maintained.
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 1, 3-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,913,061. Although the claims at issue are not identical, they are not patentably distinct from each other.
Although the conflicting claims are not identical, they are not patentable distinct from each other because Claim 1 of the instant application is generic to all that is recited in Claim 1, 9 of U.S. Patent No. 11,913,061. That is, Claims of U.S. Patent No. 11,913,061 falls entirely within the scope of Claim 1, or in other words, Claim 1 is anticipated by of Claim 1 U.S. Patent No. 11,913,061. Here, claim 1 of U.S. Patent No. 11,913,061 recites
1. A method for preparing a nucleic acid derived from a human subject, comprising collecting a skin surface lipids sample comprising secretions secreted from a sebaceous gland of the human subject on a skin surface of the human subject and isolating the nucleic acid from the collected skin surface lipids sample, wherein the nucleic acid is human RNA and wherein said collecting comprises applying to the skin surface of the human subject a surface skin lipid absorbent material which is an oil-blotting film made of polypropylene, wherein the surface skin lipid absorbent material is not a surface skin lipid adhesive material.
The method of claim 1, wherein the surface skin lipid absorbent material is used in a dry state.
With regard to Claims 2-8, ‘061 teaches Claims 2-8 that are analogous in all respects.
Response to Arguments
The response traverses the rejection. The response states the rejection will be addressed when the double patenting is the only remaining issue in the application.
Thus, for the reasons above and those already of record, the rejection is maintained.
Conclusion
No claims allowable over the art.
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.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682 April 6, 2026