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 .
Election/Restrictions
Claims 38-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1/5/2026.
Specification
The disclosure is objected to because of the following informalities: the specification only uses the abbreviation “TMPAC”. For clarity, the full chemical name should first be spelled out at least once and then referred to in parentheses:
trimethylphenylammonium chloride (TMPAC). Appropriate correction is required.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: claim 35 states the implant has an in vivo life of no more than 36 months, but this limitation is not sufficiently supported in the specification. Page 12, lines 11-17 states that the in vivo half-life may be no more than 36 months. The specification gives a different range of the in vivo life that is at least 4 weeks without an upper range.
Drawings
The drawings are objected to because the drawings have areas of dark shading obstructing the subject matter. The drawings should be black and white line drawings with shading provided by cross-hatching.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 33 and 34 are objected to because of the following informalities: for purposes of clarity, the abbreviation “TMPAC” should first be spelled out trimethylphenylammonium chloride (TMPAC). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 32-37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 32, 36 and 37 recite the term “optionally”, which renders the claims indefinite, as it is unclear whether any limitation recited after “optionally” is actually required.
Claim 32 additionally includes the term “preferably”, which also makes it unclear whether a urethane linkage is required.
Claim 33 is indefinite for its dependency on claim 32.
Regarding claim 34: claim 33 recites the TMPAC substance as an option in a list of several options for prepolymers. Therefore claim 33 does not necessarily require the prepolymer to the TMPAC substance. The reference in claim 34 to the TMPAC substance therefore lacks proper antecedent basis.
Claim 35: the limitation “the implant has an in vivo life of no more than 36 months” appears to contradict the specification on Page 12, lines 11-17, which states that the in vivo half-life may be no more than 36 months. The specification gives a different range of the in vivo life that is at least 4 weeks without an upper range. Therefore, the scope of the claim is indefinite. For purposes of expediting prosecution, the term “life” is interpreted as “half-life.”
Claim Rejections - 35 USC § 102
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) 29-32 and 35-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by USPAP 2020/0390944 (Williams et al.).
Regarding claim 29: Williams et al. disclose a void occlusion implant for inserting into a void in a body tissue, the implant comprising a polymeric material which is capable of transitioning from a compressed state to an expanded state [0795] upon exposure to a stimulus (see description of expansion in response to tissue expander [0795]); wherein in the expanded state the implant is capable of assuming the size and shape of the void (Williams discloses various types of breast reconstruction implants capable of filling a void (Fig. 6-15; [0114; 0121; 0122]).
The language “wherein the implant exhibits a peak expansion force of 0.1 to 2 N at 37°C” is considered to be a functional limitation that is not given full patentable weight. The prior art is not required to explicitly disclose this function but merely have the capability of exhibiting a peak expansion force in the range of 0.1 – 2N at body temperature. Williams discloses the implant is expanded with a force in the range of 0.2 – 22 N/cm [0795; 0797], wherein the implant is expanded within a patient having a body temperature of 37o C. Williams explains this may be “a peak expansion force”, since this may be the maximum force required to result in an expanded implant.
Regarding claim 30: the implant may be a post-lumpectomy implant. Williams discloses various types of breast reconstruction implants capable of filling a void (Fig. 6-15; [0114; 0121; 0122]).
Regarding claim 31: the implant is 3D printed (abstract; [0036]; [0540]).
Regarding claim 32: Williams discloses the implant comprises a polymeric material (abstract) formed from a resin composition [0288] comprising a prepolymer (see description of monomers such as [0089]; [0141]; [0144] for example). The resin may comprise at least one carbonate linkage (for example [0142]; [0173]; [0212]) and a urethane linkage ([0142]; [0173]).
In regard to claim 35: the phrase “the implant has in vivo life of no more than 36 months” is treated as a functional recitation, wherein the prior art is not required to explicitly disclose this rate of degradation, but to merely have a capability of being degraded within 36 months. As known in the art, the rate of degradation is based on many variables related to a particular patient, such as the size and shape of a void, patient health, etc. The term “life” is treated as the half-life, as explained above. Williams discloses that the implant is degradable [0007] and may be resorbed to a significant extent at a period of 12-15 weeks [0029]; [0483], which is considered to fall in the range of 0-36 months.
Regarding claim 36: the polymeric material comprises an imaging agent, such as a radiopaque material, a radiotracer, or a fluorescent dye [0171].
Regarding claim 37: wherein the polymeric material comprises a biologically active agent (abstract), such as an antimicrobial, an anti-inflammatory agent, a growth factor or an anti-cancer agent [0080].
Regarding claim 38: the implant is in the form of a foam or mesh having a pore size of from 50 to 250 micrometers [0578].
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) 29-38 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2020/0115490 (Dove et al.).
Dove discloses degradable polymeric materials for forming self-expanding [0003], implantable tissue scaffolds [0015] that are expandable at body temperature of 37oC ([0025]; [0069]; [0074]). Dove discloses the implant can have a variety of shapes and purposes that conform to local tissue upon self-expansion [0077].
The language “wherein the implant exhibits a peak expansion force of 0.1 to 2 N at 37°C” is considered to be a functional limitation that is not given full patentable weight. The prior art is not required to explicitly disclose this function but merely have the capability of exhibiting a peak expansion force in the range of 0.1 – 2N at body temperature. In this case, Dove discloses that the shape memory implant exerts a force on surrounding tissue when it expands [0006]. Dove discloses the material can exhibit a modulus of 1 MPa to 1 Gpa, wherein the modulus is a result effective variable that depends on the composition and geometry of the polymer [0073]. The specification of this application provides evidence that a polymer having an elastic modulus of 5Mpa to 4Gpa and a compressive modulus of 0.5 to 50 MPa (page 11, lines 1020) is capable of exhibiting an expansion force of 0.1 to 2 N (see page 11, lines 42-45). It would have been obvious to one having ordinary skill in the art at the time the invention was made to configure an implant of Dove to have a peak expansion force of 0.1 – 2N, for the purpose of tailoring the properties of the implant for a particular patient’s needs, since 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. Additionally, the Applicant does not appear to place any criticality on this range, as it is merely stated as an example in a range of options.
Regarding claim 30: Dove discloses many uses of an implant, such as an interbody spacer [0077]. Although Dove fails to explicitly disclose the term “post-lumpectomy implant”, an implantable device is capable of being placed in at least some existing void after a lumpectomy.
Regarding claim 31: the implant is 3D printed ( [0013]; [0076]).
Regarding claim 32, the polymeric material formed from a resin composition comprising a prepolymer comprising repeating units having a carbonate linkage and a diluent comprising an O=C-N linkage, such as a urethane linkage (abstract; [0058]; [0080]).
Regarding claim 33, Dove teaches the prepolymer can be 5-[(allyloxy)methyl]-5-etheyl-1,3-dioxan-2-one) or 9-(5-norbornen-2-yl)-2,4,8,10-tetraoxa-3-spiro[5.5]undecanone) [0058].
Regarding claim 34, Dove teaches the ratio of monomers TMPAC and NTC can be varied to achieve desired properties of the final polymer (see graph Fig. 8A; [0151]; [0183]; [0218]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify ratio of TMPAC and NTC of the Dove implant to be in a range of 95:5 to 5:95, as applicant appears to have placed no criticality on the claimed range, and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In regard to claim 35: as explained above, the term “life” is interpreted as “half-life.” The phrase “the implant has in vivo half-life of no more than 36 months” is treated as a functional recitation, wherein the prior art is not required to explicitly disclose this rate of degradation, but to merely have a capability of degrading at this rate. Dove discloses that the implant is degrades at least to a significant extent within a period of less than 36 months (Fig. 16A-B; [0212-0214]). Dove discloses the rate of degradation is a result effective variable based on resin composition ([0218-0219]; [0240-0246]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to configure an implant of Dove to have a half-life of no more than 36 months in order to meet particular patient’s needs, since 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. Additionally, the Applicant does not appear to place any criticality on this range, as it is merely stated as an example in a range of options.
Regarding claim 36: the polymeric material comprises an imaging agent, such as a radiopaque material, a radiotracer, or a fluorescent dye (see description of fluorescent tag at [0095] and/or iodinated at [0191]).
Regarding claim 37: wherein the polymeric material comprises a biologically active agent [0077].
Regarding claim 38: the implant is in the form of a foam or mesh having a pore size of from 200-1500 micrometers [0078].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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