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 .
Information Disclosure Statement
Since this application is a continuation of US Application 17/080728, the Examiner has considered the information provided in the parent application (per MPEP 609.02). Should Applicant desire the information to be printed in any patent issuing from this application, a new listing of the information must be separately submitted.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 18-26, in the reply filed on 07/30/2026 is acknowledged.
Claims 27-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/30/2026.
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 18-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-18 of U.S. Patent No. 12,501,966. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed structure of the present invention may be wholly derived from the claimed subject matter of the patent.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 18-20, 22-23, and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cote (US 2,163,906).
Regarding claim 18, Cote discloses a custom 3-D orthotic insert (1) comprising: a sole portion (Fig. 2); and a wedge portion (7, 8, 8’) extending from the sole portion, the wedge portion comprising a vertical portion (7, 8) and a transverse portion (8’) prior to being positioned within the patient's footwear, the transverse portion extending away from the vertical portion and being configured to be positioned over a top portion of a patient's foot (Fig. 1, 2); and an opening (9) defining a volume positioned to suspend a wound on the patient's foot within the volume of the opening, the opening positioned: on the wedge portion, wherein the sole portion and the wedge portion are configured to remove excess tolerance between the patient's foot and an internal surface of the patient's footwear (column 1, line 1-column 2, line 36; Fig. 1-3).
The limitation “wherein the sole portion and the wedge portion are custom sized based on a determined shape of the patient's foot” is a product-by-process limitation. The determination of patentability in a product-by-process claim is based on the product itself, even though the claim may be limited and defined by the process. That is, the product in such a claim is unpatentable if it is the same as or obvious from the product of the prior art, even if the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 697, 227 USPQ 964, 966 (Fed. Cir. 1985). A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. (Same cite as above)
Regarding claim 19, the sole portion and the wedge portion are configured to remove excess tolerance between the insert around the wound on the patient's foot and an internal surface of the patient's footwear.
Regarding claim 20, Cote discloses that the sole portion comprises a forefoot portion, a midfoot portion, and a hindfoot portion, and the wedge portion extends from a side of the midfoot portion (Fig. 1).
Regarding claim 22, Cote discloses that the wedge portion extends from a medial side of the midfoot portion (Fig. 1).
Regarding claim 23, Cote discloses that the wedge portion extends from a lateral side of midfoot portion (wherein flange 7 extends on a lateral side of the midfoot portion; Fig. 1, 3).
Regarding claim 25, Cote discloses that the sole portion and the wedge portion are formed of a cushioning material (column 1, lines 50-52).
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.
Claim(s) 24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cote, as applied to claims 18 and 25.
Regarding claim 24, Cote does not disclose the specific thickness of the orthotic insert, but appears to show an insert with a thickness of at least 1/8 inch (Cote Fig. 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the orthotic having a thickness of at least 1/8 inch, in order to provide sufficient comfort and support to the wearer. The claimed values are merely an optimum or workable range. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 26, Cote does not disclose that the cushioning material is foam. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the cushioning material foam, in order to use a material well known for use in shoe orthotics which is a spongy material that may absorb moisture and be shaped by pressure and reshape itself to conform to the shape of a user’s foot. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cote, as applied to claims 19 and 20, in view of Wikler (US 3,726,287).
Regarding claim 21, Cote does not disclose that the wedge portion has a greater thickness than the midfoot portion. Wikler teaches an orthotic insert (12) configured to be inserted into a footwear of the patient, the orthotic insert comprising a sole portion (16), a wedge portion (18, 20) extending from the sole portion, wherein the wedge portion comprises a vertical portion and a transverse portion (as seen in Fig. 5), the transverse portion extending away from the vertical portion and being configured to be positioned over a top portion of the foot of the patient. The wedge portion has a thickness greater than a thickness of a midfoot portion of the sole portion (Fig. 5). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the thickness of the wedge portion greater than the thickness of the midfoot sole portion, as taught by Wikler, in order to provide improved cushioning and support to the sides and/or top of the foot, depending on the needs of the individual user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON M PRANGE whose telephone number is (571)270-5280. The examiner can normally be reached M-F 8:30-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Khoa Huynh can be reached at (571) 272-4888. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHARON M PRANGE/ Primary Examiner, Art Unit 3732
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