DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
3. Applicant’s amendment of claims 1 and 2 in the reply filed on 09 February 2026 is acknowledged.
Claim Rejections - 35 USC § 112
4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
a. Claim 2 has been recently amended to include the recitation “the plates (1) overlap and collagen membranes are placed against each other” (line 11). However, the collagen membranes are not described in the specification (nor shown in the figures), as originally filed as, “placed against each other”. From Figure 3 of the instant application, the two polymer skeletons might be in direct contact with each other (difficult to discern from any of the figures). But the membranes are not shown as “placed against each other”.
6. 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.
7. Claims 1 and 2 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.
a. Regarding claim 1, the phrase "and preferably" (line 5 and line 6) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further, the term “preferably” in claim 1 is a relative term which renders the claim indefinite. The term “preferably” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
b. Claim 2 is generally narrative and indefinite, failing to conform with current U.S. practice. Claim 2 appears to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
(i) The phrase “and its mirror reflection” (line 4) is vague and confusing, rendering claim 2 indefinite as to the scope of the invention. This will be interpreted “as best understood”.
(ii) The recitation “permanently connecting the polymer skeletons with a collagen membrane” (lines 6-7) is vague and unclear, rendering claim 2 indefinite as to the scope of the invention. Claim 2 has been amended to recite “by printing directly over a collagen membrane, two polymer skeletons (2) with the shape of the lateral or medial meniscus and its mirror reflection” (lines 4-5). Is the “a collagen membrane” of line 6 the same as, or different from, the “a collagen membrane” of line 4?
(iii) Claim 2 recites the limitation "the inner edges of the plates” in line 10. There is insufficient antecedent basis for this limitation in the claim.
(iv) The recitation “the plates (1) overlap and collagen membranes are placed against each other” (line 11) is vague and unclear, rendering claim 2 indefinite as to the scope of the invention. The “and collagen membranes” exist in a vacuum, since it can’t be discerned if said membranes are the same as, or different from, the “a collagen membrane” of line 4. Further, "collagen membranes” (plural) in line 11 lacks sufficient antecedent basis for this limitation in the claim.
(v) Claim 2 recites the limitation "the edges of the inner curvature 4 of both plates” in line 12. There is insufficient antecedent basis for this limitation in the claim.
(vi) Claim 2 recites the limitation "the inner outline of the polymer skeletons” in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
8. 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 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.
9. Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Malaviya et al. (US PG Pub No. 2003/0036797 A1; cited in Applicant’s IDS).
Malaviya et al. ‘797 discloses (Figures 51-55) a collagen meniscus cap (600), characterized in that it is formed by a set of two plates (606, 608) in the shape of lateral or medial meniscus (Figures 54 and 55), each plate comprising a layer of collagen membrane (ECM sheets/laminae/panels – [0020]), placed on a polymer (ECM is a bio-polymer) skeleton (Figures 51 and 54 – skeleton formed by 620, 622, 624, 626, 628, and 630), connected by a flexible hinge (Figures 53 and 55 – “hinge” defined by inner apex 604, or “hinge” defined by outer apex 602), and the polymer skeleton has the shape of intersecting segments which form a mesh (Figures 51 and 54 - 620, 622, 624, 626, 628, and 630; further, see [0179]).
Malaviya et al. ‘797 discloses the invention as claimed, except for particularly disclosing “whereas the thickness of the collagen membrane is within the range of 0.4 mm to 0.9 mm, and preferably 0.6 mm, and the thickness of the polymer skeleton is within the range of 0.2 mm to 0.6 mm, and preferably 0.45 mm”.
It would have been obvious for a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have manufactured Malaviya et al. ‘797 collagen meniscus cap to have “whereas the thickness of the collagen membrane is within the range of 0.4 mm to 0.9 mm, and preferably 0.6 mm, and the thickness of the polymer skeleton is within the range of 0.2 mm to 0.6 mm, and preferably 0.45 mm”, 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.
The motivation would be to provide an appropriately-sized collagen meniscus cap, based on patient’s gender, age, and/or particular medical condition of the patient’s meniscus.
10. Claim 2 is rejected, as best understood, under 35 U.S.C. 103 as being unpatentable over Malaviya et al. (US PG Pub No. 2003/0036797 A1; cited in Applicant’s IDS) in view of Ghodbane et al. (WO 2018/148722 A1) and Richmond (US 4,919,667).
Malaviya et al. ‘797 discloses a method for the production of a collagen meniscus cap consists of the steps of:
using bio-absorbable and/or bio-degradable material to create two polymer (ECM is a bio-polymer) skeletons (Figures 14-16 – ECM skeleton formed by 115, 117, 119, 121, and 123; Figures 22 and 23 – ECM skeleton formed by 190, 192, 194, 196; Figures 26-30 - ECM skeleton formed by 244/246; Figures 36-39 – ECM skeleton formed by 306; Figures 51-54 – ECM skeleton formed by 620, 622, 624, 626, 628, and 630; further, see [0179]) with the shape of the lateral or medial meniscus and its mirror reflection (e.g., Figure 39);
permanently connecting the polymer skeletons with a collagen membrane to form collagen membrane plates;
the connected collagen membrane plates being cut (cut or trimmed – see [0139]; [0150]; [0155]; [0157]; [0161]; [0163]; [0177]) until they form the shape of the lateral or medial meniscus;
the cut collagen membrane plates being folded together (Figures 14, 15, 19, 22, 29, 37, and 54; further, see [0138]; [0150]; and [0161]) so that the inner edges of the plates 1 overlap and collagen membranes are placed against each other (Figures 14, 15, 19, 22, 29, 37, and 54; further, see [0138]; [0150]; and [0161]), to create a hinge (e.g., apex and/or periphery after plates are folded) of the collagen meniscus cap.
Malaviya et al. ‘797 discloses the invention as claimed, except for particularly disclosing “by printing directly over”. However, this is already known in the art. For example, Ghodbane et al. ‘722 teaches (Figures 1, 2, and 4) printing directly over a collagen membrane in order to create polymer skeletons ([0022]; [0058]; [0059]; [0091]; [0093]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of “by printing directly over”, as taught by Ghodbane et al. ‘722, with the invention of Malaviya et al. ‘797, in order to create polymer skeletons.
Malaviya et al. ‘797 discloses the invention as claimed, except for particularly disclosing then a tissue glue is used to cover the edges of the inner curvature of both plates of the collagen membrane to the inner outline of the polymer skeletons, and in turn the inner edges are glued together. However, this is already known in the art. For example, Richmond ‘667 teaches (Figures 2, 3, and 6) utilizing a tissue glue to bond layers/laminae of a meniscus cap, and hence gluing together the edge/periphery of said meniscus cap (Abstract; claim 1). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of then a tissue glue is used to cover the edges of the inner curvature of both plates of the collagen membrane to the inner outline of the polymer printout, as taught by Richmond ‘667, with the invention of Malaviya et al. ‘797, in order to glue together the edge/periphery of said meniscus cap.
Response to Arguments
11. Applicant's arguments filed 09 February 2026 have been fully considered but they are not persuasive.
a. Regarding rejection of independent claim 1 under 35 U.S.C. 103 as being unpatentable over Malaviya et al. (US PG Pub No. 2003/0036797 A1; cited in Applicant’s IDS), and rejection of independent claim 2, as best understood, under 35 U.S.C. 103 as being unpatentable over Malaviya et al. (US PG Pub No. 2003/0036797 A1; cited in Applicant’s IDS) in view of Richmond (US 4,919,667), the Applicant argues “In contrast, the essence of the present invention is a polymer skeleton (framework) made of highly durable, bioabsorbable polymer, e.g. polycaprolactan (PCL), this skeleton (framework) is in the shape of two meniscus-shaped plates connected along the inner curvature, together forming a meniscus overlay”. The Examiner respectfully disagrees.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
As previously indicated, Malaviya et al. ‘797 discloses (Figures 51-55) a collagen meniscus cap (600), characterized in that it is formed by a set of two plates (606, 608) in the shape of lateral or medial meniscus (Figures 54 and 55), each plate comprising a layer of collagen membrane (ECM sheets/laminae/panels – [0020]), placed on a polymer (ECM is a bio-polymer) skeleton (Figures 51 and 54 – skeleton formed by 620, 622, 624, 626, 628, and 630), connected by a flexible hinge (Figures 53 and 55 – “hinge” defined by inner apex 604, or “hinge” defined by outer apex 602), and the polymer skeleton has the shape of intersecting segments which form a mesh (Figures 51 and 54 - 620, 622, 624, 626, 628, and 630; further, see [0179]).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “a polymer skeleton (framework) made of highly durable, bioabsorbable polymer, e.g. polycaprolactan (PCL)”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
12. THIS ACTION IS MADE FINAL. 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.
13. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action (Ghodbane et al. - WO 2018/148722 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774