DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/21/2025 has been entered.
Claim Rejections - 35 USC § 112
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.
Claims 6-9, 11, 12, 15, 16 and 30-34 are 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.
Claims 6 and 15 require P4HB monofilament fibers having a denier per filament of less than 3 dpf and a tenacity of greater than 6.5. The limitations were added in the amendment filed 10/21/2025 without any indication where written support is located within the specification. The examiner is unable to locate written description support.
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 6-9, 11, 12, 15, 16 and 30-34 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 6 and 15 require P4HB monofilament fibers having a denier per filament of less than 3 dpf and a tenacity of greater than 6.5. It is unclear what unit of measurement is associated with the claimed tenacity of greater than 6.5.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 6-9, 15, 16 and 30-34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over USPAP 2004/0234576 to Martin in view of USPAP 2008/0227355 to Chakravarty.
Martin discloses a woven or knitted surgical mesh comprising poly-4-hydroxybutyrate (P4HB) monofilament fibers (see entire document including the abstract and [0054]).
Martin does not appear to mention the claimed denier or tenacity but Chakravarty discloses that it is known in the medical fiber art to construct PHA fibers with a denier per filament of about 0.5 to about 3 and a tenacity (strength) of about 7 (see entire document including [0025]-[0029], [0048], [0050] and [0057]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the monofilament fibers of Martin with any suitable denier per filament and tenacity, such as claimed, based on the intended use, the desired fiber fineness, and/or the desired fiber strength, and because 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 and desired characteristics.
Martin teaches in Example 1 that a spin finish (Goulston, Lurol PT-6A) was dissolved in iso-propanol at 10 vol/vol % and applied to the fiber before the first roll to act as a lubricant and protect the fiber during downstream processing. Furthermore, Martin teaches in Example 8 that the yarn knitted very well without evidence of fiber breakage even without the addition of a spin finish as a lubricant. Therefore, Martin discloses that the spin finish may be present in an amount of greater than zero weight percent or the spin finish may be preset in an amount of zero weight percent. The disclosed spin finish amount of zero weight percent is sufficiently close to the claimed amount of greater than zero weight percent to read on the claimed amount such that the prior art establishes prima facie obviousness because one of ordinary skill in the art would have expected the presence of zero weight percent spin finish to result in the same properties compared to when spin finish is present in an amount of just barely more than zero weight percent. It is noted that the current specification discloses that a spin finish amount of zero weight percent is ideal [0071].
MPEP 2144.05: A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.”). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Waite, 168 F.2d 104, 108, 77 USPQ 586, 590 (CCPA 1948); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Swenson, 132 F.2d 1020, 1022, 56 USPQ 372, 374 (CCPA 1942); In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941); In re Becket, 88 F.2d 684 (CCPA 1937) (“Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys.”); In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934); In re Lilienfeld, 67 F.2d 920, 924, 20 USPQ 53, 57 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., “not substantially less than 13%,” “not substantially below 17%,” and “between about 13[%] and 20%”); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); Gentiluomo v. Brunswick Bowling and Billiards Corp., 36 Fed. App'x 433 (Fed. Cir. 2002)(non-precedential)(disagreeing with argument that overlapping ranges were required to find a claim prima facie obvious); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of “less than 6 pounds per cubic feet” and the prior art range of “between 6 lbs./ft3 and 25 lbs./ft3” were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.).
Martin does not specifically recognize the claimed steps in producing the P4HB filament yarns. However, said limitations are considered to be a product by process limitations. Further, absent a showing to the contrary, it is the examiner’s position that the article of the applied prior art is identical to or only slightly different from the claimed article. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). The burden has been shifted to the applicant to show unobvious difference between the claimed product and the prior art product. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983). It is noted that if the applicant intends to rely on Examples in the specification or in a submitted declaration to show non-obviousness, the applicant should clearly state how the Examples of the present invention are commensurate in scope with the claims and how the Comparative Examples are commensurate in scope with the applied prior art.
Considering claim 30, Martin teaches in the embodiments in Table 1 monofilaments having a diameter between 100 and 150 microns.
Claims 11 and 12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over USPAP 2004/0234576 to Martin in view of USPAP 2008/0227355 to Chakravarty in view of USPAP 2007/0198087 to Coleman.
Martin is relied upon as set forth above in the rejection of claim 6. Martin is silent regarding the addition of antibiotic to the surgical mesh. However, Coleman teaches at [0047] a knitted surgical mesh comprising poly-4-hydroxybutyrate or P4HB multifilament yarns, which was knitted into a mesh using a single bar tricot machine. Further, Coleman teaches at [0038] that for example, an antibiotic may be added to the devices (mesh) to prevent or treat an infection. The devices may also incorporate autograft, allograft, and/or xenograft materials. Therefore, it would have been obvious to one of skill in the art before the effective filing date of this application to add an antibiotic as taught by Coleman to Martin’s mesh when it is desired to prevent or treat an infection.
Response to Arguments
Applicant's arguments filed 10/21/2025 have been considered but are partly moot in view of the new ground(s) of rejection.
The applicant asserts that Martin fails to teach or suggest the claimed polyethylene glycol sorbitan monolaurate spin finish amount of less than 0.1 weight percent and greater than zero weight percent. Applicant’s argument is not persuasive. As admitted by the applicant, Martin discloses that use of spin finish in at least Example 1 and Martin also discloses that the spin finish amount may be zero weight percent in at least Example 8. Therefore, Martin discloses that the spin finish may be present in an amount of greater than zero weight percent or the spin finish may be preset in an amount of zero weight percent. The disclosed spin finish amount of zero weight percent is sufficiently close to the claimed amount of greater than zero weight percent to read on the claimed amount such that the prior art establishes prima facie obviousness because one of ordinary skill in the art would have expected the presence of zero weight percent spin finish to result in the same properties compared to when spin finish is present in an amount of just barely more than zero weight percent. It is noted that the current specification discloses that a spin finish amount of zero weight percent is ideal [0071].
MPEP 2144.05: A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.”). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Waite, 168 F.2d 104, 108, 77 USPQ 586, 590 (CCPA 1948); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Swenson, 132 F.2d 1020, 1022, 56 USPQ 372, 374 (CCPA 1942); In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941); In re Becket, 88 F.2d 684 (CCPA 1937) (“Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys.”); In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934); In re Lilienfeld, 67 F.2d 920, 924, 20 USPQ 53, 57 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., “not substantially less than 13%,” “not substantially below 17%,” and “between about 13[%] and 20%”); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); Gentiluomo v. Brunswick Bowling and Billiards Corp., 36 Fed. App'x 433 (Fed. Cir. 2002)(non-precedential)(disagreeing with argument that overlapping ranges were required to find a claim prima facie obvious); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of “less than 6 pounds per cubic feet” and the prior art range of “between 6 lbs./ft3 and 25 lbs./ft3” were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW T PIZIALI whose telephone number is (571)272-1541. The examiner can normally be reached Monday-Thursday 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marla McConnell can be reached on 571-270-7692. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW T PIZIALI/Primary Examiner, Art Unit 1789
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