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 .
RESPONSE TO APPLICANT’S AMENDMENT
1. Applicants amendment filed on 11/14/25 is acknowledged.
Claims 1-10, 12, 20 are pending.
2. Claims 1-5 and 17-20 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 6-16 read on an immunoassay method for performing diagnosis are under consideration in the instant application.
3. 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.
4. Claims 6-10, 12-16 stand rejected under 35 U.S.C. 103 as being unpatentable over US patent 5,726064 in view of US Patent Application 20100003305 and US Patent Application 20080166745 for the same reasons set forth in the previous Office Action, mailed on 08/15/25.
Applicant’s arguments filed on 11/14/25 have been fully considered but have not been found convincing.
Applicant asserts that : (i) currently amended claim 6 clearly defines that the method of the present invention is performed by stamping an antibody containing patch and can achieve absorption of unbound antibody upon separation of the patch without a separate washing process or drying process thus obtaining accurate data; (ii ) none of the prior art references does not teach or suggest using a patch in a stamping manner
As initial matter it is noted that the amended claims do not recite using a patch in a stamping manner. Moreover, it is noted that the instant Specification does not even define or teach what stamping manner stand for.
Moreover, the arguments of counsel cannot take the place of evidence in the record. In re Schulze , 145 USPQ 716, 718 (CCPA 1965). See MPEP 716.01© Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long - felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant.
With regards to Applicant’s statement that “none of the prior art references does not teach or suggest using a patch in a stamping manner”.
It has been recently stated that KSR forecloses the argument that a specific teaching, suggestion, or motivation are required to support a finding of obviousness See Board decision ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
In addition, all the prior art references teaches the use of immunoassays methods comprising contacting and separation technique. Applicant’s provided no explanation or evidences of why it would not be obvious to one skill in the art to combine all the teaching of the prior art references to performed an immunoassay method as instantly claimed.
As has been stated previously, US Patent’064 teaches an immunoassay method for performing diagnosis by detecting target protein comprising using patch that containing antibody. US Patent’064 teaches that said patch contains cavities that can contain a liquid substance ( see entire document, paragraphs 21, 23, 65, 66, 68, 78 in particular).
It is noted that US Patent’064 does not explicitly teaches that said patch includes a mesh structural body forming micro-cavities that is configurated to contain a liquid substances
US Patent’305 teaches a device to be used for various applications comprising a patch that contains mesh structure and antibody which attached to said patch ( see entire document, paragraphs 0155,0156 in particular)
US Patent’305 teaches a device patch comprising a mesh structural body that may contain reagent within nano-size range.
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a patch which includes a mesh structural body forming micro-cavities in an immunoassay method taught by US Patent’064 with a reasonable expectation of success because the prior art suggests can patch which includes a mesh structural body forming micro-cavities is an obvious variation of the patch taught by US Patent’064.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
From the teachings of the references, it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
5. 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.
6. Claims 1-10, 12-16 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of US Patent 12181390. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-13 of US Patent 12181390 recited an immunoassay method comprising using a patch that contains the antibody and which includes a mesh structural body forming micro-cavities and is configurated to contain a liquid substance.
It is noted that Applicant requested to hold that double patenting rejection in abeyance until allowable subject matter is identified.
7. The claims 6-10, 12-16 stand provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Applications No. US 20250067642 A1; US 20230194398 A1; US 20190064140 A1; US 20230194398 A1
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims of copending Applications No. US 20250067642 A1; US 20230194398 A1; US 20190064140 A1; US 20230194398 A1 each recited an immunoassay method comprising using a patch that contains the antibody and which includes a mesh structural body forming micro-cavities and is configurated to contain a liquid substance.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
It is noted that Applicant requested to hold that provisional double patenting rejection in abeyance until allowable subject matter is identified.
8. Claims 6-10, 12-16 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Applications No US 20230009655 A1, US 20190049349 A1; US 20230009655 A1
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims of copending Applications No US 20230009655 A1, US 20190049349 A1; US 20230009655 A1 are drawn a patch that contains the antibody and which includes a mesh structural body forming micro-cavities and is configurated to contain a liquid substance that are used in the presently claimed method, and wherein the presently claims method is disclosed in the specification of the Applications No US 20230009655 A1, US 20190049349 A1; US 20230009655 A1.
This rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
It is noted that Applicant requested to hold that provisional double patenting rejection in abeyance until allowable subject matter is identified.
9. No claim is allowed.
10. THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). 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 extension fee 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel Kolker can be reached on 571/ 272-3181
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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