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 .
Priority
This application claims priority from provisional application 62/792,867, filed 01/15/2019.
Status of Claims
Claims 1-20 are pending.
Claims 4-20 have been withdrawn from consideration.
Election/Restrictions
Applicant’s election without traverse of Species 4 (Figures 18-19) and Sub-Species L (Figure 39) in the reply filed on 11/26/2025 is acknowledged.
It is noted that the applicant’s response stated Species 1 but refers to Figures 18-19 of Species 4. The examiner is interpreting this as an election of Species 4. Confirmation is required.
The applicant withdrew claims 6 and 11-20, but upon further review claims 4-20 should have all been withdrawn as being directed at non-elected embodiments. Specifically claims 4-5 and 7-8 define the gaps as varying but this is shown in non-elected Figure 40, which is described by the original disclosure as a modification of Figure 39. The elected Figure 39 includes constant gaps. Additionally claims 9-10 describe the gaps as getting progressively larger from the center, which again is shown in non-elected Figure 40. Therefore claims 4, 5, and 7-10 have all been withdrawn from consideration.
Information Disclosure Statement
The Information Disclosure Statements filed on 09/09/2022 has been considered by the examiner. It is noted that two copies of the same IDS have been entered into the file.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke § 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke § 112(f) except as otherwise indicated in an Office action.
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim1 and 21 of U.S. Patent No. 10,966,832 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Specifically, the patent defines the invention as a compliant biological scaffold in the independent claim and the application defines the invention as a compliant scaffold. Claim 2 of this application then defines the current invention as comprising a biologic scaffold which makes it consistent in scope with the patented independent claim. Patented claim 21 and pending claim 3 both define the source of the material as being from a living organism.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of copending Application No. 17/222,868 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Specifically, the copending application defines the invention as an in vivo biological scaffold material in the independent claim and the application defines the invention as a compliant scaffold. The recitation of in vivo is inherent to all these types of medical implants. Claim 2 of this application then defines the current invention as comprising a biologic scaffold which makes it consistent in scope with the copending independent claim. Additionally copending claim 2 and current claim 3 both define the source of the material as being from a living organism.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dell et al US 2004/0260315 A1.
1. Dell discloses a compliant scaffold (Figures 3A-B) comprising:
a) a plurality of elongated apertures 103 in said compliant scaffold that forms a geometric pattern (Figures 3A-B), each of said plurality of elongated apertures comprising;
i) a pair of nodes (midpoints along each slit 103); and
ii) a pair of antinodes (the opposing endpoints of each slit 103);
wherein the pair of nodes are centrally located along the elongated aperture with a first node on a first side of the elongated aperture and a second node on a second side of the elongated aperture (the nodes are the midpoint of the left and right sides of each slit); and
wherein a first antinode is configured on a first antinode end of the elongated aperture and a second antinode is configured on a second antinode end of the elongated aperture (the antinodes are the extreme endpoints of the entire slit);
b) a plurality of geometric shapes having a bounded perimeter formed by said plurality of elongated apertures (Figures 3A-B);
wherein upon biaxially expanding the compliant scaffold, the first and second nodes separate from each other and wherein a distance between the antinodes contracts to form an arrangement of tessellated apertures in the compliant scaffold (Figures 3A-B);
wherein the plurality of elongated apertures forms said geometric pattern with a substantial portion of elongated apertures configured with the antinodes proximal to one of said pair of nodes of a separate elongated aperture; wherein the antinodes are closer to said one of said pair of nodes than to any other antinode (each row of apertures is axially offset compared to the previous row, this moves the antinodes to the claimed configuration); and
wherein the plurality of elongated apertures comprises expanded elongated apertures (Figure 3B).
2. 3. Dell discloses the compliant scaffold comprises biological material derived from a living organism [0001] [0023].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christopher D. Prone/Primary Examiner, Art Unit 3774