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 .
DETAILED ACTION
Status of Claims
The amendments and arguments filed on 03/03/2026 are acknowledged and have been fully considered. Claims 30 and 39-52 are now pending. Claims 1-29 and 31-38 are canceled; claims 30 and 39 are amended; claims 40-52 new.
Claims 30 and 39-52 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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.
Claim 39 is 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 39 recites that the VEGF concentration is about 5pg/mg however claim 30 (from which 39 depends on) recites that the VEGF concentration is at least about 30 pg/mg. The amount of claim 39 falls outside of the amount of claim 30. A similar issue is present with the TIMP-2 concentration. One with ordinary skill in the art would not understand the metes and bound of the claim as written, and as such it is indefinite. For purposes of search and consideration, the claim is understood to read “VEGF concentration is about 50 pg/mg, and the TIMP-2 concentration is about 10 pg/mg.”
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 39 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 39 fails to further limit the subject matter of claim 30, upon which it depends, as it recites concentrations of VEGF and TIMP-2 that are outside of the range recited in claim 30. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 30 and 39-52 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017076782 A1 (Novahep AB, 2017; as submitted on IDS of 09/09/2021) in view of US Patent 11602548 B1 (Klitzke, 2023; filing date of 02/25/2019) evidenced by Technote (2014).
In regards to claim 30, Novahep teaches a composition comprising the extracellular matrix (ECM) components of a mammalian tissue (see abstract). The mammalian tissue is taught to be a decellularized mammalian tissue (see paragraph 0006) that is obtained from the placenta (see paragraph 0007) of a pig (see paragraph 0008; paragraph 0062) (i.e. a decellularized, porcine ECM). Novahep teaches that the composition is used to heal wounds (see paragraph 0009; paragraph 0062). VEGF is taught to be in the composition (see Novahep, claims 4, 28, and 65; paragraphs 0059 and 0067). It is also taught that the porcine scaffolds are washed with sodium dodecyl sulfate (SDS) (i.e. a detergent) (see paragraphs 0091-0092).
The teachings of Novahep are silent on the use of a protease with the specific detergent of sodium linear alkylaryl sulfonate, the use of TIMP-2, and the amount of VEGF increasing or decreasing in concentration.
Klitzke teaches a method of forming a composition from porcine placental membrane tissue comprising a detergent treatment step (see Klitze, column 1, lines 33-57). The detergent is taught to comprise sodium linear alkylaryl sulfonate (i.e., an anionic detergent), phosphates, and at least one protease, such as Tergazyme ™ (see Klitzke, column 2, lines 39-49; column 6, lines 5-24). Tergazyme ™ is known to have a 7.5% content of phosphorus (see Technotes, page 1 whole).
In regards to claims 51 and 52, it is taught that the detergent is present in a concentration of about 0.25% to about 3% w/v and the porcine placental membrane is placed in about 20 mL of a detergent solution per gram of placental tissue (see Klitzke, column 6, lines 5-24). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claims 30 and 51-52, 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 formulate the scaffold as instantly claimed using the teachings of Novahep and Klitzke as both references are drawn to using healing wounds using porcine placental membrane tissue (see Novahep, paragraph 0009; paragraph 0062; Klitzke, column 3, lines 36-42). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One with ordinary skill in the art would be motivated to combine the teachings of Novahep with the detergent of Klitzke according to the known method of treating porcine placental membrane tissue to form a wound healing composition (see Klitzke, columns 10-11, Example) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
In regards to the limitation of “wherein the decellularized, porcine placental…unprocessed porcine placental membrane”, a product-by-process claim drawn to a composition directed towards the composition, the patentability of a product does not depend on its method of production. Novahep and Klitzke teaches the instantly claimed scaffold. "[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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). "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 a nonobvious difference between the claimed product and the prior art product. The teachings of Novahep and Klitzke establish the scaffold as instantly claimed, thus the burden shifts to the applicant to come forward with evidence showing that the process of making the scaffold as instantly claimed produces a materially different product than the composition of Novahep and Klitzke.
Further in regards to claims 30 and 39-50, MPEP §2112.01(I) states that “[w]here 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.” As the combination of Novahep and Klitzke teaches the same method of treatment of the porcine scaffold, the prior art renders obvious the instant composition. In regards to claims 30 and 39-48, a person with ordinary skill in the art would reasonably expect that the concentrations of TIMP-2 and VEGF would be the same as what is instantly claimed as the composition of the prior art is made in an identical method using the same compounds. In regards to claims 49-50, a person of ordinary skill in the art would reasonably expect the same composition to have the same properties, such as the TIMP-2 being reduced by 95% relative to native porcine placental membrane and VEGF concentration being increased by at least 70-fold relative to native porcine placental membrane, as instantly claimed.
Response to Arguments
Applicant's arguments filed 03/03/2016 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
Applicant’s arguments with respect to references Reing, Tom, Urdaneta and Yusouf have been considered but are moot because the new ground of rejection does not rely on these references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In regards to applicant’s argument that Novahep does not provide statistical comparison between processed material relative to native tissue, it is pointed out that the combination of Novahep and Klitzke yield an identical method of producing the composition as claimed and as such, the prior art renders obvious the instant composition. In regards to claims 30 and 39-48, a person with ordinary skill in the art would reasonably expect that the concentrations of TIMP-2 and VEGF would be the same as what is instantly claimed as the composition of the prior art is made in an identical method using the same compounds.
Applicant argues against the product-by-process argument presented by examiner, however it is pointed out that the method of making the composition in this case does not hold patentability as discussed above. It is noted that while the method of making the composition is not patentable, it does not mean that the method of making is irrelevant, as the prior art teaches a method that is identical to that which is claimed (i.e., detergent treatment with specific compounds in specific amounts) and as such one with ordinary skill in the art would reasonable expect that the same composition is formed from the same method. The fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant is reminded that whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). In the instant case, applicant says data is presented that shows unexpected results, however attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See MPEP § 2129 and § 2144.03 for a discussion of admissions as prior art. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c). "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992).
As such the claims are rendered obvious as discussed above.
Conclusion
No claims 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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/ISIS A GHALI/ Primary Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611
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