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 .
Response to Amendment
Applicant's amendment and argument filed 04/29/2026 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-2, 4-10, 12-13, 15-19, 21, 24, 28 and 30 are pending of which claims 1-2, 4-10, 12-13 and 15-19 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on
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.
Response to Arguments
Applicant's arguments filed 04/29/2026 have been fully considered but they are not persuasive. The applicant’s assertion that the Office’s analysis of the judicial exception being incorrect because the analysis should be to blood is incorrect. The applicant believes that the analysis of the natural counter part should be to blood, however the applicant is not claiming blood and thus this assertion is erroneous. The analysis is done to the platelets and “deleterious factors” so broadly claimed, presumably components already found excreted by cells in the body such as cytokines. These too are judicial exceptions and although the applicant is claiming judicial exceptions with other certain judicial exceptions being removed this is still the same as claiming animal extracted components as discussed in the rejection above. The cytokines and/or platelets still exert the same activities in the human body as they would being claimed outside and together in different amounts. The applicant argues that there are notable differences when the deleterious factor is removed and points to figures of the invention (see argument at page 2, bottom). These activities are derived from the judicial exceptions. TGF-beta1 has many different activities in the body and mechanisms in which it can exert an effect. Same as with platelets. The applicant is still merely claiming those judicial exceptions and removal of another judicial exception from which the first judicial exception may come in contact with does not change those exceptions in any meaningful way. These components indeed interact in the body and have similar activities and would be expected to have similar activities when they are not in contact with each other. The cells of the release different cytokines in response to many stimuli. The cytokines are found in the body and indeed are found coming into contact with platelets at specific biological moments. These activities that can exist naturally do not appear different from what is being tested. The applicant is simply removing a cytokine that may inhibit tissue repair at certain times and this is not enough to overcome the fact that the applicant is still only claiming natural judicial exceptions.
It would be advised to claim the composition in a formulation that is not naturally found in nature or amend the claims to recite some limitation which they believe is functional outside of what is not found in nature. The applicant is merely claiming judicial exceptions as currently claimed.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peter Mariner et. al. (US10016505B2), hereinafter Mariner. This rejection is maintained with slight modifications to take into account the arguments filed on 04/29/2026.
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 also discloses selectively activated platelet releasate serum (SAPRS) and removing clotting factors (see example 9). Here Mariner teaches removing clotting factors which are known to come from platelets and can be considered deleterious factors which inhibits growth, repair and/or healing.
Response to Arguments
Applicant's arguments filed 04/29/2026 have been fully considered but they are not persuasive. The applicant arguments are directed at example 6, however the Office shows that Mariner teaches removing clotting factors from activated platelet releasate as just discussed. The applicant argues that Mariner does not describe the platelets being activated however this limitation is described.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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). This rejection is maintained due to the arguments filed on 04/29/2026.
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.
Response to Arguments
Applicant's arguments filed 04/29/2026 have been fully considered but they are not persuasive. The applicant argues that LaPrade teaches beneficial release of factors from activated platelets and that the teaching described wherein VEGF has differential effects on target tissues and PDGFs as well depending on timing will have different effects is not enough of a teaching to those having ordinary skill to remove them from activate PRP during tissue repair. This teaching is exactly why one would remove them from the composition because their inclusion would make it more difficult for someone to know if including then with the PRP composition would exert a positive healing effect rather than a deleterious one. For example, LaPadre discusses how including VEGF can increase graft laxity after ACL repair.
Conclusion
Currently no claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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 BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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