*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 .
Applicant’s response dated September 23, 2025 is acknowledged.
Priority
This application is a 371 of PCT/US18/51355 filed on 09/17/2018, which claims benefit
in provisional application 62/559,268 filed on 09/15/2017.
Claim Status
Claims 1-72 were canceled. Newly added claims 73-88 read on the elected invention and
are examined on the merits.
Withdrawn Claim Rejections — 35 USC § 103 and 112
All previous rejections of claims 65-72 are withdrawn because claims 65-72 were canceled.
New Claim Rejections — 35 USC § 112
Necessitated by Amendment
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 79 and 87 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 79 requires “body temperature”. The phrase is indefinite because the scope of the temperature is unknown since the claim does not specify what “body” is referring to.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) INGENERAL.—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 77, 84, 86, and 88 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.
Claim 88 introduces new matter because it requires the thiol groups to be crosslinked in the gel resin without irradiation. Page 10 line 5 of the specification teaches “The construct will polymerize with time, so no additional polymerization methodology (e.g. UV light) is required”. This teaching is not sufficient to exclude “irradiation” from the claim. The teaching provides support for excluding irradiation by UV light from the claim, but a teaching of UV light is not sufficient to provide support for excluding all methods of irradiation.
In the remarks dated September 23, 2025, applicant traversed the rejection of claim 47 made in final office action dated November 29, 2024 because newly added claim 88 recites the limitation “without irradiation” that was rejected as new matter in the previous office action.
Paragraph bridging pages 9-10 of the specification describes how the composition is used to engineer tissues in the body, where the composition is placed into tissue defect and allowed to polymerize with time, so no additional methodology (e.g. UV light) is require.
This passage broadly provides support for excluding polymerization methodologies that exclude polymerization in situ, and provides support for excluding UV light irradiation as the specific methodology for crosslinking the composition. UV light irradiation does not provide support for every type of irradiation that is known for crosslinking claimed polymers. UV light irradiation was provided as an exemplary crosslinking method that is not required, which is not sufficient to provide support for the entire genus of irradiation methods known to be useful for crosslinking. For example, polymers are known to crosslink across the entire spectrum of wavelengths, and even under visible light. There is no indication in the specification that applicant contemplated excluding every wavelength other than wavelengths that fall under UV. A recitation of a species (UV light irradiation) does not provide support for the entire genus.
Claims 77, 84, and 86 recites a range of 0.57 or greater. This limitation is new matter because the specification provides support for 0.57, which is not sufficient to support values greater than 0.57.
New Claim Rejections — 35 USC § 103
Necessitated by Amendment
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.
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 73-76, 78-83, 85, 87, and 88 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy et al. (US 2014/0342015 Al Published November 20, 2014 — of record in PTO-892 dated 12/05/2022), Detamore (US 2016/0235892 A1, Published August 18, 2016 — of record in IDS dated 10/21/2022), and Prestwich (WO 2004/037164, Published May 6, 2024 — of record in PTO-892 dated 06/21/2024).
The claims encompass a composite biomaterial for tissue regenerative medicine.
The teachings of Murphy are related to compositions for tissue regeneration comprising cell-free amniotic membrane powder. The composition is a hydrogel scaffold (Abstract). The composition is in the form of a powder, an ointment, or an aerosol spray (paragraph 0008). The scaffold comprises hyaluronan (paragraph 0010). The method of making the powder includes decellularizing the amniotic membrane (paragraph 0011). Paragraph 0189 teaches the method of making the hydrogel, where hyaluronic acid and gelatin are thiolated, and then crosslinked with PEGDA in the presence of a photoinitiator.
Murphy does not teach particle size of the powder.
The teachings of Detamore are related to compositions comprising decellularized cartilage tissue powder in the form of paste, putty, hydrogel, and scaffolds, and methods of using the compositions for treating osteochondral and cartilage defects (Abstract). In one embodiment, a composition comprising the decellularized cartilage tissue powder having particulates ranging in size from 1 nm to 500 microns and a hydrogel is disclosed. Hydrogel is a water-soluble crosslinked network of polymer chains and hydrogel may be prepared from hyaluronate, among others (paragraph 0011).
Murphy and Detamore do not teach the concentration of carboxyl groups that are converted to thiol groups in the thiolated hyaluronic acid.
The teachings of Prestwich are related to methods of making crosslinked compounds via the reaction between at least one thiol compound with at least one thiol-reactive compound (Abstract). Figure 14 shows structures of a,b-unsaturated esters and amides of poly(ethylene glycol) crosslinked with thiolated HA and thiolated gelatin (page 4 lines 12-13). Figure 1 depicts one aspect of the method for producing a first thiolated compound having the formula II, where Y is hyaluronan. The first step involves reacting a macromolecule having the formula Y-COOH
with the dihydrazide/disulfide compound having the formula A. The reaction is performed in the presence of a condensing agent. A condensing agent is any compound that facilitates the reaction between the dihydrazide group of compound A and the COOH group on the macromolecule, In one aspect, the condensing agent is a carbodiimide, including, but not limited to, l-ethyl-3-[3- (dimethylamino)propylcarbodiimide (EDCD (page 8 lines 1-22). The thiol-reactive compound has formula V (page 15 lines 10-22). Compositions comprising the crosslinked compounds are useful for tissue regeneration. Compositions can be placed into soft tissue, hard tissue, surgical incisions, and skin surface among others (paragraph bridging pages 29 and 30). Page 39 describes a method of preparing thiolated HA, where degree of substitution and thiol content were defined as the number of DTP or DTB residues and thiols per 100 disaccharide units, respectively. Degree of substitution was mainly controlled by the molar ratios of HA, DTP, and EDC and reaction time. By selecting suitable reaction parameters, the degree of substitution can be controlled over a wide range. Table 1 shows degree of substitution varying from 26.8% to 66.8% (page 40).
The teachings of Murphy, Detamore, and Prestwich are related to compositions comprising a hyaluronate hydrogel intended for tissue regeneration, and it would have been obvious to have combined them because they are in the same field of endeavor.
Regarding claims 73, 80, 82, and 83, it would have been prima facie obvious to a person of ordinary skill in the art before effective filing date of the claimed invention to have formed a composite biomaterial comprising a hydrogel formed by crosslinking thiolated hyaluronic acid and gelatin with PEGDA, and a powder formed from decellularized amniotic tissue, with a reasonable expectation of success because Murphy teaches composites for tissue regeneration formed by combining a hydrogel formed by crosslinking thiolated hyaluronic acid and gelatin with PEGDA, and a powder formed from decellularized amniotic tissue.
Murphy does not teach particle sizes of the powder. It would have been obvious to the skilled artisan to look to Detamore because Detamore is concerned with composite biomaterials formed from powders of decellularized tissue and hyaluronate hydrogel. It would have been prima facie obvious to have formed Murphy’s powder having a particle size in the range from 1 nm to 500 microns, with a reasonable expectation of success because it was known from Detamore that 1 nm to 500 microns is a suitable range of particle sizes of powders formed from decellularized tissue intended for making tissue regeneration composites. The selection of a known particle size range suitable for its intended purpose supports obviousness. The claim
requires microparticles, which is obvious because Detamore teaches a range of particles that encompasses particle sizes in the micron range.
Murphy does not teach the concentration of carboxylic acid groups converted to thiol groups in thiolated hyaluronic acid. A person skilled in the art would have been motivated to look to the teachings of Prestwich because Prestwich teaches a method of making thiolated hyaluronic acid and crosslinking the thiolated HA with PEGDA via a thiol-ene reaction to make a material intended for tissue regeneration. It would have been obvious to have formed Murphy’s composite using Prestwich’s hydrogel formed by crosslinking thiolated HA with PEGDA, wherein the thiolated HA comprise 26.8-66.8% of carboxylic acid groups converted to thiol groups and wherein the thiolated HA react with olefin groups in PEGDA, with a reasonable expectation of success because Prestwich teaches a method of thiolating HA by converting carboxylic acid groups to thiol groups and where the thiol content and degree of substitution per 100 disaccharide units ranges from 26.8 to 66.8%, and crosslinking the thiolated HA with PEGDA to form a hydrogel suitable for tissue regeneration. A disaccharide unit of hyaluronic acid contains one carboxylic acid group and each substituent introduces a thiol group, thus a degree of substitution of 26.8-66.8% results in 26.8-66.8% of carboxylic acid groups converted to thiol groups. One of skill in the art would have had a reasonable expectation of success in using Prestwich’s hydrogel in Murphy’s composite because Prestwich’s hydrogel is intended for tissue regeneration. The selection of a known material suitable for its intended purpose supports obviousness.
The claimed range of 15-30% in claims 73 and 80 are obvious because the range overlaps with 26.8-66.8% and it has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists.
The claimed range of 15-25 % in claim 82, and claimed range of about 25 % in claim 83 are obvious because the ranges are close enough to 26.8-66.8% that a person skilled in the art would have expected them to have the same properties. See MPEP 2144.05(I).
Claim 73 defines the gel resin as a product by process. Murphy’s hydrogel comprises a reaction product of thiolated hyaluronic acid and PGDA where the thiol of HA reacted with the vinyl group in PEGDA, which meets all of the structural requirements of the claimed gel resin. The product by process limitation was taken into consideration when determining obviousness, and since Murphy’s product of thiolated HA and PEGDA is a hydrogel that formed by crosslinks forming between the thiol group of HA and the vinyl group of PEGDA, it is the examiner’s position that Murphy’s hydrogel is structurally the same as claimed gel resin because both are made formed by crosslinking thiolated HA and PEGDA at the same moieties. Additionally, the Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature than when a product is claimed in the conventional fashion. See MPEP 2113.
Regarding claim 74, Murphy describes decellularization of amniotic membrane in paragraphs 0181-0188. Murphy does not state whether or not the powder is crystalline or amorphous. The powder is either crystalline or amorphous and it would have been obvious to have used either one.
Regarding claim 75, Murphy teaches that the composite comprises at least one biopolymer selected from hyaluronan, agarose, gelatin, and collagen, wherein in one embodiment at least one biopolymer is thiolated (paragraph 0015). Thus, it would have been obvious to have formed the composite with a mixture of thiolated and native biopolymers such as thiolated hyaluronan and collagen or thiolated hyaluronan and agarose.
Regarding claims 76 and 81, the claimed particles size range of tissue microparticles is obvious because it overlaps with the range of 1 nm to 500 microns.
Regarding claim 78, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have formed a composite biomaterial comprising decellularized cartilage tissue powder having particulates ranging in size from 1 nm to 500 microns and a hydrogel comprising crosslinked hyaluronate, with a reasonable expectation of success because Detamore teaches a composite comprising decellularized cartilage tissue powder having particulates ranging in size from 1 nm to 500 microns where the composite is intended for treating osteochondral and cartilage defects. Detamore does not teach thiolated hyaluronic acid crosslinked with PEGDA. It would have been obvious to a person skilled in the art to replace Detamore’s hydrogel comprising crosslinked hyaluronic acid with a gel formed from thiolated hyaluronic acid crosslinked with PEGDA, with a reasonable expectation of success because it was known form Murphy and Prestwich that a gel formed by crosslinking thiolated hyaluronic acid with PEGDA is suitable for making a composite with particles of decellularized tissue. It would have been obvious to have used thiolated HA having 26.8-66.8% carboxylic acid groups converted to thiol groups with a reasonable expectation of success because Prestwich teaches thiolated HA having 26.8-66.8% carboxylic acid groups converted to thiol as suitable for crosslinking with PEGDA to form hydrogels intended for tissue regeneration. The selection of a known material suitable for its intended purpose supports obviousness.
Regarding claim 79, it would have been prima facie obvious to a person of ordinary skill in the art before effective filing date of the claimed invention to have formed a composite biomaterial comprising a hydrogel formed by crosslinking thiolated hyaluronic acid and gelatin with PEGDA, and a powder formed from decellularized amniotic tissue, with a reasonable expectation of success because Murphy teaches composites for tissue regeneration formed by combining a hydrogel formed by crosslinking thiolated hyaluronic acid and gelatin with PEGDA, and a powder formed from decellularized amniotic tissue.
Murphy does not teach particle sizes of the powder. It would have been obvious to the skilled artisan to look to Detamore because Detamore is concerned with composite biomaterials formed from powders of decellularized tissue and hyaluronate hydrogel. It would have been prima facie obvious to have formed Murphy’s powder having a particle size in the range from 1 nm to 500 microns, with a reasonable expectation of success because it was known from Detamore that 1 nm to 500 microns is a suitable range of particle sizes of powders formed from decellularized tissue intended for making tissue regeneration composites. The selection of a known particle size range suitable for its intended purpose supports obviousness. The claimed particle size range is obvious because overlaps with the range of 1 nm to 500 microns.
Murphy does not teach the concentration of carboxylic acid groups converted to thiol groups in thiolated hyaluronic acid. A person skilled in the art would have been motivated to look to the teachings of Prestwich because Prestwich teaches a method of making thiolated hyaluronic acid and crosslinking the thiolated HA with PEGDA via a thiol-ene reaction to make a material intended for tissue regeneration. It would have been obvious to have formed Murphy’s composite using Prestwich’s hydrogel formed by crosslinking thiolated HA with PEGDA, wherein the thiolated HA comprise 26.8-66.8% of carboxylic acid groups converted to thiol groups and wherein the thiolated HA react with olefin groups in PEGDA, with a reasonable expectation of success because Prestwich teaches a method of thiolating HA by converting carboxylic acid groups to thiol groups and where the thiol content and degree of substitution per 100 disaccharide units ranges from 26.8 to 66.8%, and crosslinking the thiolated HA with PEGDA to form a hydrogel suitable for tissue regeneration. A disaccharide unit of hyaluronic acid contains one carboxylic acid group and each substituent introduces a thiol group, thus a degree of substitution of 26.8-66.8% results in 26.8-66.8% of carboxylic acid groups converted to thiol groups. One of skill in the art would have had a reasonable expectation of success in using Prestwich’s hydrogel in Murphy’s composite because Prestwich’s hydrogel is intended for tissue regeneration. The selection of a known material suitable for its intended purpose supports obviousness.
The claimed range of 15-30% is obvious because it overlaps with 26.8-66.8%. See MPEP 2144.05(1).
The phrase “the thiol groups are cross-linkable in the gel resin at body temperature and without irradiation and wherein the composite biomaterial can adopt a shape that matches or approximates a tissue void to be filled in a subject” describes properties of the gel resin and the composite. The prior art gel resin and composite meets all of the structural limitations of the instantly claimed gel resin and composite and it would have been reasonable to expect the prior art composite to have the same properties as claimed composite when placed under identical conditions, absent evidence to the contrary. The claim does not actually require the claimed product to be formed by crosslinking at body temperature and without UV irradiation; and the claim does not actually require the composite to be shaped.
Claims 85, 87, and 88 describe the hydrogel of claim 80 as a product by process. The claims are obvious because prior art composite meets all of the structural limitations of the claimed composite. The process by which the claimed product was formed and structure implied by the process were taken into consideration, and the prior art composite could have been formed by the claimed processes absent evidence to the contrary. "[E]ven 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.” See MPEP 2113.
Claims 77, 84, and 86 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy, Detamore, and Prestwich as applied to claims 73-76, 78-83, 85, 87, and 88 above, and further in view of Winterbottom (US 2005/0251267 Al Published November 10, 2005 — of record in PTO-892 dated 05/22/2023).
Murphy, Detamore, and Prestwich do not teach density of the tissue microparticles within the gel resin at or beyond a percolation threshold.
The teachings of Winterbottom are related to an implant comprising a cell conducting phase and a binder phase (Abstract). The cell conducting phase comprise a cell-free bone derived material (paragraph 0031). The binder phase is a hydrogel (paragraph 0079). The cell conducting phase of the composite may provide a continuous path for cell migration and tissue ingrowth across the entire composite or a portion of the composite. In many embodiments, the cell conducting phase is comprised of particulate material. Use of particulates facilitates molding
structures fabricated with the composite. Furthermore, contiguity of the components of the cell conducting phase promotes transformation of the composite. In order to optimize the contiguity of the cell conducting phase, percolation theory is exploited. Percolation theory addresses the mathematical modeling of connectivity (contiguous adjacency) of randomly distributed components in a system. The percolation threshold P: is the volume fraction at which adjacent randomly distributed components will form one path spanning the system (FIG. 3). Below Pc, there is not enough of the included component to provide a continuous path across the system (paragraph 0096). To increase the probability that the cell conducting phase provides a path to the interior of the composite, it may be necessary to increase the proportion of the cell conducting phase beyond the percolation threshold (paragraph 0098). Increasing the volume fraction of the cell conducting phase within the matrix increases the continuity of the cell conducting phase and allows cells to reach more of the interior of the composite without blockage by the binder phase. Too great a volume fraction of the cell conducting phase may degrade the mechanical properties if there is not sufficient binder phase to hold the particles and pieces of the cell conducting material together. The desired volume fraction of the cell conducting phase may depend on the shape of the cell conducting material because of the effect of particle shape on both connectivity and mechanical properties. In one embodiment, the volume fraction of the cell conducting phase is at least about 27%, about 35%, about 40%, or about 50%. To optimize biological performance of the implant, the proportion of the cell- conducting phase may be as high as practicable. In practice, this ideal may be limited by other considerations. For instance, a minimum amount of the binding phase may be necessary to provide particular mechanical properties to the implant. Likewise, certain forming processes can be limited in their ability to form an implant containing high levels of solids. Evenly
proportioned particles may have less surface area for a given volume than elongated particles. A single elongated particle or a piece of tendon can reach deep into the composite material, while an evenly proportioned particle of the same volume does not provide a path for deep cell infiltration (paragraph 0101).
The teachings of Winterbottom and Murphy modified with Detamore and Prestwich are related to composite biomaterials formed from particles and a gel, and it would have been obvious to have combined them because they are in the same field of endeavor.
It would have been prima facie obvious to have formed Murphy’s composite as modified by Detamore and Prestwich where the microparticles are packed at or beyond a percolation threshold within the gel resin, with a reasonable expectation of success because it was known from Winterbottom that in order to increase the probability that the cell conducting phase provides a path to the interior of the composite, it may be necessary to increase the proportion of the cell conducting phase beyond the percolation threshold. Increasing the volume fraction of the cell conducting phase within the matrix increases the continuity of the cell conducting phase and
allows cells to reach more of the interior of the composite without blockage by the binder phase. One of skill in the art would have been motivated to form the composite of Murphy in view of the teachings of Winterbottom because Murphy teaches using the composite for tissue regeneration. It would have been obvious to have formed the composite where the volume fraction of the microparticles is at least about 27%, about 35%, about 40% or about 50%, with a reasonable expectation of success because Winterbottom teaches that increasing the volume fraction of the cell conducting phase increases continuity of the cell conducting phase and allows cells to reach more of the interior of the composite and teaches at least 27%, about 35%, about 40% or about 50%, as a suitable volume fractions of the microparticles in the composite.
Combining prior art elements according to known methods to obtain predictable results supports obviousness.
Response to Arguments
Applicant’s arguments submitted in the remarks dated September 23, 2025, were fully considered to the extent that the arguments apply to current rejections. The arguments are not persuasive for the following reasons.
Applicant’s arguments under “The same “field of endeavor” is not the relevant test for obviousness” are not persuasive because the office action articulates as to why the claimed invention is obvious over the cited reference. The office action describes the teachings of the main references, which limitations are missing from the main references, and why it would have been obvious to modify the main references in view of secondary references to arrive at the claimed invention, which is sufficient for an obviousness rejection.
Applicant’s arguments under “Prestwich fails to teach that the percentages of the carboxyl groups in the hyaluronic acid converted to thiol groups is a result effective variable, which is a required showing for a rejection based upon a range taken from a prior art references such as Prestwich” are not persuasive because the rejection is not based on a “result effective variable” rationale. The claimed range of 15-30% is obvious because it overlaps with the prior art range, and that is sufficient for an obviousness rejection.
Per MPEP 2144.05:
In 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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
Concentration ranges 15-25% and 25% are obvious because the concentration ranges are close enough to the prior art range that the skilled artisan would have expected them to have the same properties, which is sufficient for an obviousness rejection.
Per MPEP 2144(I)
Similarly, 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 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 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)(the prior art, which taught about 0.7:1 of alkali to water, renders unpatentable a claim that increased the proportion to at least 1:1 because there was no showing that the claimed proportions were critical); 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); 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.).
Further with regards to claimed range, the specification was reviewed and there is no evidence that any of the claimed ranges are critical.
Applicant’s argument “The range cited in Prestwich is broad and fails to teach Applicant’s claimed that the percentage of the carboxyl groups with sufficient specificity” is not persuasive because “sufficient specificity” is not the standard for obviousness rejections, and the claimed ranges are not rejected under the “sufficient specificity” rationale. The rationale applies to anticipation rejections.
Applicant’s argument “Switching from amniotic tissue to tissues cited in claim 78 would make the primary reference, Murphy, unsatisfactory for its intended purpose.” is not persuasive because rejection of claim 78 relies on Detamore as the primary references, which teaches cartilage. Claim 78 lists cartilage in the list of alternatives. The rejection does not suggest modifying Murphy by replacing amniotic tissue with cartilage.
Applicant’s argument “The intended use of a prior art product has little to no bearing on the reasonable expectation of success in making Applicant’s claimed invention using a combination of references” is not persuasive because the combination of prior art references teaches a composition that meets all of the structural limitations of the instantly claimed composition, therefore the prior art composition could have been used for the claimed intended use. Additionally, cited prior art is concerned with materials used for tissue engineering which is the same as applicant’s intended use.
Applicant’s argument “The product produced without irradiation, or UV irradiation, imparts distinctive structural characteristics to the final product, which the Examiner fails to recognize.” is not persuasive because the claimed structural limitations are met by the teachings of the prior art. The product is described as a product by process and the process of making is taken into consideration when determining obviousness. In the instant case, the claims require a crosslinked polymer and the cited prior art teaches a crosslinked polymer. There is nothing in the instant claims that structurally distinguishes the claimed product from the prior art product. The Office does not have the means to manufacture claimed product and prior art product to determine structural differences.
Per MPEP 2113
"[E]ven 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."
"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product.
"[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Office personnel should note that reliance on the alternative grounds of 35 U.S.C. 102 or 35 U.S.C. 103 does not eliminate the need to explain both the anticipation and obviousness aspects of the rejections.
In response to applicant’s argument that the Examiner dismissed teachings from the specification, while the claims are read in light of the specification it is improper to import limitations from the specification into the claims.
The office does not have the means to test prior art products to determine if applicant’s product has the same or different characteristics.
Per MPEP 2112.01
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 re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Applicant’s argument “The cited combination of references do not teach a volume fraction of the tissue microparticles within the gel resin is about 0.57 (57%).” is not persuasive Winterbottom teaches that cell conducting phase includes tissue derived materials, and prior art’s tissue microparticles are considered tissue derived materials.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ALMA PIPIC/
Primary Examiner, Art Unit 1617