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
Applicant’s election without traverse of invention I, claims 1-8, 20, and 21 in the reply filed on 3/26/2026 is acknowledged. Claims 10-16, 19, and 23-32 are withdrawn without traverse as being directed to a nonelected invention.
Status of the Claims
Claims 1-8, 10-16, 19-21, 23-25, and 27-32 are pending. Claims 1-8, 20, and 21 are under current examination. Claims 10-16, 19, and 23-32 are withdrawn.
Claim 19 has the improper status identifier. The status identifier must be amended to read “Claim 19. (Withdrawn)”.
Comments
The title of the application contains the serial number of the application. This appears to be due to a processing error. The title of the application has been corrected to remove the serial number, as in “Compositions and Methods for Soft Tissue Augmentation”.
Claim Objections
Claims 2-7 and 20-21 are objected to because of the following informalities:
The dependent claims 2-7 lack the article “The” at the beginning of each claim. See MPEP 608.01(n)(IV).
Claims 20 and 21 depend from claim 10, which as has been withdrawn. Where possible, claims are to be complete in themselves. MPEP 2173.05(s). Rewriting the claims in independent form would be remedial.
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 2, 5-7, and 20-21 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.
Claim 2 recites the limitations “low shear stress” and “high shear stress”. The terms “low” and “high” in claim 2 are relative terms which renders the claim indefinite. The terms “low” and “high” are 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. With no definition of “low” and “high” provided, it is impossible to discern the shear stress needed in order for the composition to flow as a viscous fluid.
Regarding claim 5, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation “8kDa to 200kDa”, and the claim also recites “often from 85kDa to 186kDa, usually from 146kDa to 186kDa” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 6, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation “80% to 100%”, and the claim also recites “often from 87% to 99.9%, and usually from 99% to 99.9%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 7, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Regarding claims 20 and 21, the elected claims 20 and 21 require the limitations of the withdrawn claim 10. Withdrawn claim 10 recites the limitations “a temperature of 0oC”, “an interior shape of the container”, and “a temperature of the poly(vinyl alcohol)”. This language renders the claims indefinite because it suggests that there could be greater than one freezing or heating temperature or one interior shape of the container. Amending the claim to recite "the temperature" or “the interior shape of the container” would obviate the rejection. This will not raise concerns over antecedent basis because the heating and freezing temperature and the interior shape of the container is an inherent property of the method. Withdrawn claim 10 also recites the limitations “low shear stress” and “high shear stress”. The terms “low” and “high” in claim 10 are relative terms which renders the claim indefinite. The terms “low” and “high” are 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. With no definition of “low” and “high” provided, it is impossible to discern the shear stress needed in order for the composition to flow as a viscous fluid. The Examiner notes that the withdrawn claim 10 is not included in the rejection as it is not instantly being examined.
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.
Claims 1-3 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Porter (U.S. Patent Application No. 2004/0157953, publication year: 2004, cited in the IDS filed 10/12/2023).
Regarding claims 1, Porter discloses a material for filling a cavity in the body comprising a Bingham plastic (Claims 1 and 2).
Regarding claim 3, Porter discloses that the low-viscosity pre-polymer material with a light activated sensor may be housed in a syringe and inserted into the body (Fig. 2 and [0004]).
Claim 2 and 20 are product-by-process claims. According to MPEP 2113: product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art” therefore claims 2 and 20 are interpreted to claim 1.
Claim Rejections - 35 USC § 102/103
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 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-8, and 20-21 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ku (U.S. Patent No. 6,231,605, issue year: 2001, cited in the IDS filed 10/12/2023).
Regarding claims 1, 2, and 7, Ku teaches a non-dehydrated polyvinyl alcohol (PVA) hydrogel construct which is capable of being molded into a number of shapes, and which is capable of retaining a wide range of mechanical strengths for various applications (col. 2 lines 32-37). The hydrogel tissue replacement construct is especially useful in surgical and other medical applications as an artificial material for replacing and reconstructing soft tissues in humans and other mammals (col. 3 lines 11-14). In a preferred embodiment, the hydrogel is produced in a two-stage process. In the first stage a mixture of PVA and water is placed in a mold, and repeatedly frozen and thawed, in cycles, until a suitable hydrogel is obtained. In a second stage, the hydrogel is removed from the mold, placed in water and undergoes at least one further freeze-thaw cycle until desirable mechanical properties are achieved (col. 4 lines 55-60). Generally, increasing the number of freeze/thaw cycles increases the tensile strength and tensile stiffness of the hydrogel. Lower numbers of freeze/thaw cycles can be employed because lower tensile strength and lower tensile stiffness are desirable (col. 7 lines 2-8). The freeze/thaw cycle promotes an interlocking mesh or entanglement between molecules of PVA to create the mechanical strength. This is different than the traditional cross link accomplished by chemical cross-linking agents which inevitable introduces a toxic agent into the biomaterial, thus decreasing the biocompatibility of materials which utilize chemical cross-linking agents (col. 8 line 64-col. 9 line 3). With regard to the Bingham plastic limitation of the instant claims, Ku teaches the same production process as claimed in the instant claim 2 and therefore, the Bingham plastic properties at low and high shear stress are necessarily present; the Examiner directs attention to MPEP 2112.01 (I) which states: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.”
In the alternative, the tensile strength and tensile stiffness of the hydrogel, and therefore the Bingham plastic properties, are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal tensile strength and tensile stiffness of the hydrogel in order to best achieve the desired results as such would provide advantageous mechanical strength of the hydrogel. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Ku teaches that increasing the number of freeze/thaw cycles increases the tensile strength and tensile stiffness of the hydrogel. Lower numbers of freeze/thaw cycles can be employed because lower tensile strength and lower tensile stiffness are desirable (col. 7 lines 2-8). The Examiner considers it prima facie obvious to optimize the number of freeze/thaw cycles, and therefore the tensile strength and stiffness of the hydrogel, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the number of freeze/thaw cycles have a direct effect on the tensile strength and stiffness of the hydrogel and therefore is an optimizable variable.
Regarding claim 4, Ku teaches that the mixture can be poured into one or more pre-sterilized molds. The shape and size of the mold may be selected to obtain a hydrogel of any desired size and shape. Vascular grafts can be produced by pouring the mixture into an annular mold (col. 6 lines 4-11).
Regarding claim 5, Ku teaches that PVA having an average molecular weight of from about 85,000 to 186,000 is preferred for practicing the invention (col. 5 lines 16-17).
Regarding claim 6, Ku teaches that the preferred PVA typically has a degree of saponification (or hydrolysis) in excess of 99% (col. 5 line 29).
Regarding claims 8 and 21, Ku teaches that the PVA hydrogel can also comprise a bioactive agent (col. 7 line 46).
Regarding claim 20, Ku teaches the relevant limitations of claim 1 above.
Claims 20 and 21 are product-by-process claims. According to MPEP 2113: product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art” therefore claims 20 and 21 are interpreted to claim 1.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ku (U.S. Patent No. 6,231,605, issue year: 2001, cited in the IDS filed 10/12/2023), as applied to claims 1-2, 4-8, and 20-21 above, and further in view of Porter (U.S. Patent Application No. 2004/0157953, publication year: 2004, cited in the IDS filed 10/12/2023).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Ku renders obvious the relevant limitations of claim 1 as described above. Ku also teaches that the freeze/thaw cycle promotes an interlocking mesh or entanglement between molecules of PVA to create the mechanical strength. This is different than the traditional cross link accomplished by chemical cross-linking agents which inevitable introduces a toxic agent into the biomaterial, thus decreasing the biocompatibility of materials which utilize chemical cross-linking agents (col. 8 line 64-col. 9 line 3).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Ku does not teach that the composition is present in a container and configured to be extruded from the container into soft tissue. However, this deficiency is cured by Porter.
Porter discloses a material for filling a cavity in the body comprising a Bingham plastic (Claims 1 and 2). The low-viscosity pre-polymer material with a light activated sensor may be housed in a syringe and inserted into the body (Fig. 2 and [0004]). Methods for obtaining solutions that exhibit pseudo-plastic behavior include formulation a compound which exhibits the behavior and using it directly [0016].
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art of filing to inject the PVA hydrogel of Ku into a body cavity using the method disclosed by Porter. One would have understood in view of Porter that a Bingham plastic material may be contained within a syringe and injected into a body cavity. The PVA hydrogel of Ku avoids the use of toxic chemical crosslinkers by employing a freeze/thaw cycle to form the hydrogel with the desired mechanical properties. One of ordinary skill in the art would have been capable of applying this known method of enhancement (the PVA hydrogel of Ku that avoids use of chemical crosslinkers) to the known device (the injectable Bingham plastic composition of Porter) that was ready for improvement and the results (injection of a Bingham plastic material into a body cavity) would have been predictable to one of ordinary skill in the art. The artisan of ordinary skill in the art would have had reasonable expectation of success because Porter teaches that the methods for obtaining solutions that exhibit pseudo-plastic behavior include formulation a compound which exhibits the behavior and using it directly [0016]. See MPEP 2143 (I) (D).
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 1-2, 4-8, 20, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 6,231,605.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims.
Inter alia, the claims of the ‘605 patent embrace a biocompatible hydrogel joint resurfacing agent comprising a semi-crystalline organic polymer and water. The construct is prepared by freezing and thawing the semi-crystalline organic polymer mixture with a mold at least once to create an interlocking mesh between semi-crystalline organic polymer molecules to create the semi-crystalline organic polymer hydrogel. The hydrogel is allowed to expand within the mold and then the hydrogel is immersed in aqueous solution and subjected to freezing and thawing at least once while immersed in water. The hydrogel may comprise polyvinyl alcohol. The specification of the ‘605 patent teaches that PVA having an average molecular weight of from about 85,000 to 186,000 is preferred for practicing the invention (col. 5 lines 16-17) and that the preferred PVA typically has a degree of saponification (or hydrolysis) in excess of 99% (col. 5 line 29). The Examiner has relied upon the specification to delineate the scope of the invention embraced by the ‘605 patent, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797. The biocompatible hydrogel may further comprise a eukaryotic cell such as endothelial cell, aortic endothelial cells, smooth muscle cells, fibroblasts, dermal fibroblasts, and connective tissue cells. The Examiner considers the eukaryotic cells embraced by the claims of the ‘605 patent to read on the “bioactive agent” limitation of the instant claims 8 and 21.
Instant claims 20 and 21 are product-by-process claims. According to MPEP 2113: product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art” therefore instant claims 20 and 21 are interpreted to instant claim 1.
With regard to the Bingham plastic limitation of the instant claims, the claims of the ‘605 patent teaches the same production process as claimed in the instant claim 2 and therefore, the Bingham plastic properties at low and high shear stress are necessarily present; the Examiner directs attention to MPEP 2112.01 (I) which states: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.”
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 6,231,605, as applied to claims 1-2, 4-8, 20, and 21 above, and further in view of Porter (U.S. Patent Application No. 2004/0157953, publication year: 2004, cited in the IDS filed 10/12/2023).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims.
Inter alia, the claims of the ‘605 patent embrace the relevant limitations as described above. The claims of the ‘605 patent do not embrace the composition of matter present in a container and configured to be extruded from the container into soft tissue. However, this deficiency is cured by Porter. Porter discloses a material for filling a cavity in the body comprising a Bingham plastic (Claims 1 and 2). The low-viscosity pre-polymer material with a light activated sensor may be housed in a syringe and inserted into the body (Fig. 2 and [0004]). Methods for obtaining solutions that exhibit pseudo-plastic behavior include formulation a compound which exhibits the behavior and using it directly [0016].
It would have been prima facie obvious to one of ordinary skill in the art of filing to utilize the hydrogel embraced by the claims of the ‘605 patent as an injectable into the body cavity. One would have understood in view of Porter than a Bingham plastic material is suitable for injection into a body cavity and in view of the claims of the ‘605 patent is produced by the same freeze-thaw process as instantly claimed. It would have been obvious that the composition embraced by the claims of the ‘605 patent may be present in a syringe and injected into soft tissue in the process described by Porter. The artisan of ordinary skill would have had reasonable expectation of success because Porter teaches that methods for obtaining solutions that exhibit pseudo-plastic behavior include formulation a compound which exhibits the behavior and using it directly [0016]. See MPEP 2144.07.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH ANNE MEYERS whose telephone number is (571)272-2271. The examiner can normally be reached Monday-Friday 8am-5pm ET.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617
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