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 .
This action will replace the Non-final action mailed on 12/02/2025 as there was an incorrect citation relied upon and not supplied in the previous IDS.
Election/Restrictions
Applicant's election with traverse of Group III, in the reply filed on 09/05/2025 is acknowledged. The traversal is on the ground(s) that the applicant believes that since the corresponding PCT application was found to have unity of invention they believe that this would indicate there is a requirement for examination of all inventions. This is not found persuasive because patent examiners are not beholden to have the same opinions or actions as the corresponding PCT examination process, and as described in the election/restriction previously mailed to the applicant, unity of invention was broken due to the fact that the special technical feature was previously described in the prior art (see restriction filed on 07/15/2025).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-2, 4-10, 12-13 and 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/05/2025.
Claims 21, 24, 28 and 30 are being examined on the merits.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21, 24, 28 and 30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a platelet-rich-plasma composition. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising platelet-rich-plasma, the claims are directed to a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claim states the nature-based products which are platelet-rich-plasma the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within animals. Platelets and plasma are both found naturally in animals and the applicant appears to merely be claiming those components with a deleterious factor of the PRP which inhibits growth, repair or healing to be removed. This equates to an animal extract. The process of creating an animal extract is by partitioning the starting animal material into separate compositions based upon some property. In this case the applicant is selectively removing a deleterious factor for tissue repair etc, which would still leave behind many judicial exceptions such as the platelets and plasma and other cytokines or growth factors in the plasma. The closest naturally occurring counterparts of extracted components are those same components when found existing in the animal in an unseparated form, even when purified and/or concentrated because they are chemically identical to the extracted compounds/components. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found in the animals the come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application.
This judicial exception is not integrated into a practical application because the PRP composition is only comprising the nature-based components and the only other additional elements to consider are the relative amounts (platelet-rich) and a kit comprising a container with the composition. The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)).
The claims as a whole do not amount to more than the recited exceptions because there aren’t any other additional elements to consider besides the kit which does not add an inventive concept to the claims.
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.
Claim 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peter Mariner et. al. (US10016505B2), hereinafter Mariner.
Mariner describes “the disclosure provides biomaterials including scaffolds that include blood products including blood fractions and products including platelets for administration to subjects in need thereof. More specifically, the scaffolds based on step growth polymers are enriched with blood extracts that contain platelet rich plasma (PRP) and/or extracts of platelets” (see abstract). Mariner discloses wherein the platelet require activation through means of exposure to negatively charged surfaces such as certain types of glass, activation of PARs, increased ADP concentrations, collagen exposure or increased calcium (see column 22, lines 60-65). Mariner discloses removal of soluble platelet growth factors and cytokines (see example 6. Isolation of PRP Extract, column 64) and when so broadly claimed this removal of soluble platelet growth factors and cytokines would read on deleterious factors because if all soluble growth factors and cytokines are removed then the deleterious ones would have been removed as well.
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 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 21, 24, 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Robert F. LaPrade et. al. (Biologic treatments for sports injuries II think tank – current concepts, future research, and barriers to advancement, Part 2, Orthop. J. Sports Med., 2016, March 31;4(3):2325967116636586).
LaPrade teaches that “After activation, platelets release growth factors almost immediately with total elution within 1 hour, and the half-life of growth factors is a matter of minutes to hours. Furthermore, each cytokine will contribute differently to the repair process at different time points after injury or repair. For example, PDGFs may have a more pronounced effect on tendon cellular maturation and biomechanical strength when delivered at 1 week compared with earlier delivery. Hence, the timing for PRP delivery remains an important consideration for optimizing tendon healing and should be considered in future studies. To enable meaningful assessment of the effectiveness of PRP across studies, researchers must take care to characterize the composition of biologic compounds and standardized delivery protocols” (see page 6).
“Numerous cytokines and growth factors can be found in the rotator cuff in predictable expression patterns early in the healing process. These factors function primarily to promote the inflammatory response/angiogenesis (vascular endothelial growth factor [VEGF] basic fibroblast growth factor [bFGF], PDGF); increase cellular proliferation, differentiation, and matrix synthesis (TGFb);” (see Growth Factors first para, page 3).
“VEGF describes a family of signaling proteins that stimulate vasculogenesis through tyrosine kinase receptor mediated signaling cascades. No specific study has evaluated VEGF augmentation of rotator cuff repairs, although conflicting results have been achieved in animal models of Achilles tendon healing and anterior cruciate ligament (ACL) reconstruction. Application of VEGF improved tendon tensile strength in a rat model of Achilles tendon repair while ACL grafts soaked in VEGF prior to implantation in a sheep model of ACL repair resulted in increased graft laxity” (see Growth Factors 3rd para, page 3).
LaPrade describes kits (see table 2, page 6).
LaPrade does not specifically teach removal from activated PRP releasate a deleterious factor of the PRP, however LaPrade teaches wherein PDGF and/or VEGF can potentially impair healing. Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to remove PDGF and/or VEGF because these are known pro-inflammatory cytokines which have to be circulating in the blood in a timely manner and/or can potentially impair healing. For instance, PDGF at after 1 week as described by LaPrade appears to be most effective for tissue repair. LaPrade also describes wherein VEGF can increase graft laxity after ACL repair. It would have been obvious to remove only the “deleterious factors” or essentially only the deleterious factors as claimed because by definition a deleterious factor would be one that would cause harm or damage and thus removal of these is prima facie obvious. It would have been obvious to create a kit with a container as this is commonly done in the art.
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMAN
Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655