DETAILED ACTION
Claims 1-18 are currently pending.
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 .
Priority
Acknowledgement is made of the instant application which claims the benefit of provisional application No. 63/436,121, filed December 19, 2024.
Information Disclosure Statement
No Information Disclosure Statement has been filed at this time.
Drawings
The drawings are objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)). The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: typographical.
Please review the data for Melanin/Cell column of Table 5, it appears the exponents should be negative.
For example, for Control data the calculation is:
0.05515 melanin ÷ 177,221 melanocytes = 3.11 x 10 -7
Appropriate correction is required.
Claim Objections
Claim 6 is objected to because of the following informalities: typographical.
It is noted the phrase “…the growth factors is selected from…” should read “…the growth factors are selected from…”.
Appropriate correction is required.
Claim Interpretation
Regarding claims 1-16, it is noted that claims 1-16 are directed to a composition comprising platelets and/or growth factors. Although claim 1 recites that the composition is “for inhibiting generation of melanin”, this limitation is considered only to be directed to intended use which does not further define or limit the composition, per se. Compositions are defined by their physical, structural, and chemical properties, not by an intended use or application. Please note that it is well settled that “intended use” of a composition or product, e.g., “for inhibiting generation of melanin”, will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In re Hack 114, USPQ 161. See MPEP 2111.02
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 1-2, 6, 13 and 17-18 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. Claims 1, 6 and 13 recite the following:
A composition for inhibiting generation of melanin, comprising platelets and/or growth factors isolated from blood.
6. The composition of claim 1, wherein the growth factors is selected from platelet-derived growth factor-BB (PDGF-BB) or transforming growth factor (TGF-β).
13. The composition of claim 1, wherein the composition is a dry powder prepared by freeze-drying.
As currently drafted claim 1 encompasses any amount of platelets (e.g., 1, 5, 10).
However, a review of the specification shows only a very specific range of concentration of platelets ranging from 1 x 107 to 10 x 1010 ([0022]-[0024], [0035]-[0037], [0050] and [0108]).
Claim 1 encompasses any growth factor (e.g., Brain-derived neurotrophic factor (BDNF), Bone morphogenetic proteins (BMPs)). However, although Sthalekar et al (set forth below; PTO-892) teaches that platelets release growth factors such as platelet-derived growth factor (PDGF), epidermal growth factor (EGF), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), insulin growth factor (IGF), and transforming growth factor-beta (TGF-β) (left col, page 552), Applicant’s disclosure does not support the broad scope of claimed growth factors, such as Brain-derived neurotrophic factor (BDNF) and Bone morphogenetic proteins (BMPs), for example.
Claim 1 encompasses any amount of growth factor (e.g., 0.001 ng/mL, 10 g/ml). However, a review of the specification shows only a very specific range of concentration of PDGF-BB, 0.1 ng/ml to 5 ng/ml ([0009], [0026]-[0029], [0038]-[0041] and [0052]) and TGF-β1, 0.1 ng/ml to 50 ng/ml ([0010], [0030] –[0033], [0042]-[0045] and [0053]).
Claims 2, 6 and 13 are rejected based on their dependency from claim 1.
Further regarding claims 17-18, claim 17 recites the method comprises administering the composition of claim 1 to a subject suffering from a skin pigmentation and thus encompasses human treatment. However, a review of the specification shows Applicants have not provided sufficient description of the invention to support they were in possession of the invention as currently claimed. The specification does not disclose any in vivo experimental data regarding human or non-human animal subjects suffering from melasma or hyperpigmentation. Applicant’s specification only sets forth cell-based, in vitro administration of the claimed compositions comprising platelets and/or growth factors (e.g., [0066]-[0070]; [0073]-[0078]; [0092]-[0098]; [0108]-[0113]; Table 4).
A review of the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of the invention as currently claimed.
Accordingly, the claims are considered to lack sufficient written description and are properly rejected under 35 USC 112, first paragraph.
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 17 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 17 recites the method is for “alleviating skin pigmentation” and thus renders the claim indefinite since it is unclear how one suffers from skin pigmentation since native skin comprises some level of skin pigmentation.
In the interest of compact prosecution, claim 17 is interpreted as reducing skin pigmentation. However, despite the above interpretation, such treatment does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action. The rejection to claim 17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, stands and must be addressed.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The rationale set forth below conforms to current Office practice for examination of claims under § 101.
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. All of the claims are directed to a statutory category, e.g., a composition (Step 1: YES).
The next part of the analysis involves whether the claimed invention recites or is directed to one or more judicial exceptions (Step 2A, prong one).
Claims 1 and 2 recite a composition comprising platelets and/or growth factors isolated from blood (claim 1) or isolated from plasma (claim 2).
It is noted there is no indication that the isolation of the platelets and/or growth factors from their native environment results in any markedly different characteristic regarding function or structure, as compared to the nature-based product in its natural state, therefore the claimed platelets and growth factors are considered a natural phenomenon.
As is recognized by the instant specification ([0059] and [0101]), the growth factor and platelets of the present invention are isolated from the whole blood of human or non-human mammals. Thus, the claim recites natural products.
Further regarding the embodiment encompassing a combination of platelets and growth factors, there is no indication in the specification that in combining the platelets and growth factors, that any characteristics (structural, functional, or otherwise) are developed by either the platelets or the growth factors that are not present in the individual parts. The combination does not improve or change in any way each components natural functioning. Thus, the claimed composition does not have markedly different characteristic from what occurs in nature and is a "product of nature" exception. Accordingly, the claims are directed to an exception (Step 2A, prong one: YES). Thus, the claims do not qualify as eligible subject matter, and are rejected under 35 U.S.C. 101.
Claim 6: claim 6 depends directly from claim 1, and further defines the growth factors as PDGF-BB and TGF-B1, these limitations do not limit the claimed composition in such a way that is markedly different in structure or biological and/or pharmacological function from their natural counterparts.
Claims 3-5 and 7-12: claim 6 depends directly from claim 1, and further defines the growth factors as PDGF-BB and TGF-β1, these limitations do not limit the claimed composition in such a way that is markedly different in structure or biological and/or pharmacological function from their natural counterparts.
Thus, the claimed composition does not have markedly different characteristics from what occurs in nature and is a "product of nature" exception. Thus, the claims do not qualify as eligible subject matter, and are rejected under 35 U.S.C. 101.
The next part of the analysis involves whether the claimed invention recites additional elements that integrate the judicial exception into a practical application (Step 2A, prong two).
Given the claims are directed to a composition, the claims do not recite additional steps that integrate the judicial exception into a practical application (Step 2A, prong two: No).
The final part of the analysis involves whether the claimed invention, as a whole, recite something “significantly more” than the judicial exceptions (Step 2B).
In view of the above and considered as a whole, the claimed composition does not have markedly different characteristics from what occurs in nature and such elements discussed above are not significantly more than the indicated judicial exceptions. Thus, the claims do not qualify as eligible subject matter, and are rejected under 35 U.S.C. 101 (Step 2B: NO).
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(s) 1-2, 6 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sthalekar et al., (Indian Dermatology Online Journal, Vol 12, Issue 4, July-August 2021, pages 549-554; PTO-892) (“Sthalekar”).
Sthalekar is directed to therapies for treating melasma (i.e., alleviating skin pigmentation) and teaches of a modified platelet-rich plasma (PRP) technique comprising Yuskin®, a growth factor concentrate (GFC) product. Sthalekar teaches Yuskin® growth factor concentrate (GFC) is a modified PRP technique, where patient’s blood is processed to produce a high concentration of growth factor released after platelet activation. Subjects having Fitzpatrick skin type IV–V were administered GFC monotherapy in three separate sessions, day 0, day 30 and day 60. The 8 mL of collected platelet-rich plasma comprising GFC was injected intradermally (i.e., administered) to the subjects. Sthalekar teaches the GFC monotherapy treatment resulted in significant improvement in melasma, thus suggesting that GFC therapy can be a safe, effective, and new option in the armamentarium of melasma management (Abstract; left col, first para and right col, first para, page 550).
Sthalekar teaches the GFC was prepared as per instructions given in company-provided pack insert, wherein about 16 ml of subjects’ blood was withdrawn with aseptic precaution into the kit and was processed to give final outcome of about 8 ml of GFC. Sthalekar teaches the GFC product comprises autologous growth factors derived from platelets (right col, second para, page 552), wherein platelets release growth factors such as platelet-derived growth factor (PDGF), epidermal growth factor (EGF), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), insulin growth factor (IGF), and transforming growth factor-beta (TGF-β) (left col, page 552).
Thus, Sthalekar teaches a method for alleviating skin pigmentation, specifically melasma, by administering a composition comprising growth factor concentrate (GFC) derived from blood platelets, thus anticipating claims 1-2, 6 and 17-18.
Claim(s) 1 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al., (The International Journal of Biochemistry & Cell Biology 36 (2004) 1482-1491; see PTO-892) (“Kim”).
Kim is directed to studies on the effects of TGF-β1 on melanogenesis (Abstract).
Regarding claims 1 and 10-12, Kim teaches a composition comprising TGF-β1, at concentrations ranging from 1 to 20 ng/ml (Fig. 1). Kim teaches that TGF-β1 inhibits melanin synthesis and the TGF-β1-induced hypopigmentation was found to be correlated with reduced tyrosinase activity (Fig. 1; Fig. 4B; 4. Discussion, right col, first para, page 1487). Thus, Kim anticipates claims 1 and 10-12.
Claim(s) 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Landesberg et al., (J Oral Maxillofac Surg 58:297-300, 2000; see PTO-892) (“Landesberg”).
Landesberg is directed to quantification of growth factor levels in platelet-rich plasma (PRP) (Purpose, page 297).
Regarding claims 1-5, Landesberg teaches second spin platelet compositions obtained from patients 1, 2 and 3, wherein whole blood platelet concentration was 2.06 x 108/ml, 2.94 x 108/ml and 1.73 x 108/ml, respectively (Table 2). Table 2 of Landesberg further shows platelet concentrations upon second spin concentration at 100g, 200g and 250g. The platelet concentrations for patients 1, 2 and 3 at 250g were 5.23 x 108/ml, 8.00 x 108/ml and 5.70 x 108/ml, respectively. It is noted the ranges disclosed by Landesberg are disclosed with sufficient specificity to constitute an anticipation. See MPEP 2131.03 (II)
Thus, Landesberg’s teaching anticipates claims 1-5.
Regarding claims 6-9, Landesberg teaches quantification of PDGF in the PRP (platelet-rich plasma) compositions using microtiter plates precoated with PDGF-AA monoclonal antibodies, wherein PRP samples were applied to the plate and incubated for 2 hours, thereafter washed and a conjugated antibody to PDGF-BB was added and incubated with the samples for 2 hours. PDGF-AB concentrations were measured as ng/3ml of PRP (QUANTIFICATION OF TGF AND PDGF IN PRP PREPARATIONS, page 298).
Landesberg’s Table 4 teaches the PDGF-AA/PDGF-BB concentrations in plasma samples for patients 1, 2 and 3 were 3.11 ng/3 mL, 2.00 ng/3 mL and 1.88 ng/3 mL, respectively, which correlates to 1.03 ng/mL, 0.67 ng/mL and 0.63 ng/mL, respectively.
It is noted the ranges disclosed by Landesberg are disclosed with sufficient specificity to constitute an anticipation. See MPEP 2131.03 (II)
Thus, Landesberg’s teaching anticipates claim 6-9.
Regarding claims 10-12, Landesberg teaches measuring the concentration of TGF-β1 in the PRP compositions for patients 1, 2 and 3 (Table 3), wherein the TGF-β1 concentrations for patients 1, 2 and 3 were 3.89 ng/3 mL, 4.97 ng/3 mL and 7.66 ng/3 mL, respectively, which correlates to 1.29 ng/mL, 1.66 ng/mL and 2.55 ng/mL, respectively (QUANTIFICATION OF TGF AND PDGF IN PRP PREPARATIONS, page 298).
It is noted the ranges disclosed by Landesberg are disclosed with sufficient specificity to constitute an anticipation. See MPEP 2131.03 (II)
Thus, Landesberg’s teaching anticipates claim 10-12.
Claim(s) 1-2, 6, 13 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chan et al., (US 2015/0080300; see PTO-892) (“Chan”).
Chan is directed to platelet-rich plasma growth factor concentrates, for cosmetic treatment (Abstract).
Regarding claims 1-2, 6, 13 and 17-18, Chan teaches of preparing the growth factor concentrate from platelet-rich plasma (PRP) and preserving the growth factor concentrate by freeze-drying ([0011]-[0017]), wherein the growth factor concentrate is preserved for an extended period of time ([0018]). Chan teaches the application of the growth factors on the skin reduces dark spots and pigmentation (claims 17-18) ([0004]). Chan further teaches the growth factor concentrate includes different kinds of growth factors including Platelet Derived Growth Factor (PDGF), Transforming Growth Factor Beta (TGF-B), Insulin-like Growth Factor (IGF-1), Platelet Factor-4 (PF-4), Vascular Endothelial Growth Factor (VEGF), Epidermal Growth Factor (EGF), Hepatocyte Growth Factor (HGF), Bone Morphogenetic Proteins (BMPs) and Fibroblast Growth Factor (FGF) (claim 6)([0057]).
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.
Claim(s) 3-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sthalekar, as applied to claims 1-2, 6 and 17-18 above, and further in view of Landesberg (set forth above).
The teaching of Sthalekar is set forth above and anticipates claims 1-2, 6 and 17-18.
Regarding claims 3-5, it is noted that Sthalekar does not further teach the concentration of platelets in the platelet-rich GFC composition. However, Sthalekar administers about 8 mL of the platelet-rich GFC composition obtained from human whole blood. Landesberg, at Table 2, of evidences platelet concentrations that are present in human platelet-rich plasma from three patients. The platelet concentrations prior to enrichment ranged from 1.73 x 108/ml to 2.94 x 108/ml, and upon enrichment, the platelet concentrations ranged from 3.13 x 108/ml to 9.35 x 108/ml.
Therefore, absent evidence to the contrary, it is reasonable to consider the platelet-rich GFC product of Sthalekar would have platelet concentrations ranging from a minimum of 1.73 x 108/ml to as many as 9.35 x 108/ml, thus meeting the limitation of claims 3-5.
Regarding claims 7-9, although Sthalekar teaches that platelet-rich plasma comprises PDGF, Sthalekar does not further comment on the concentration of PDGF-BB. However, Landesberg teaches quantification of PDGF in the human PRP (platelet-rich plasma) compositions using microtiter plates precoated with PDGF-AA monoclonal antibodies, wherein PRP samples were applied to the plate and incubated for 2 hours, thereafter washed and a conjugated antibody to PDGF-BB was added and incubated with the samples for 2 hours. PDGF-AB concentrations were measured as ng/3ml of PRP (QUANTIFICATION OF TGF AND PDGF IN PRP PREPARATIONS, page 298).
Landesberg’s Table 4 teaches the PDGF-AA/PDGF-BB concentrations in plasma samples for patients 1, 2 and 3 were 3.11 ng/3 mL, 2.00 ng/3 mL and 1.88 ng/3 mL, respectively, which correlates to 1.03 ng/mL, 0.67 ng/mL and 0.63 ng/mL, respectively.
Therefore, absent evidence to the contrary, it is reasonable to consider the platelet-rich GFC product of Sthalekar would have PDGF-AA/PDGF-BB concentrations ranging from a minimum of 0.63 ng/mL, to as many as 1.03 ng/mL, thus meeting the limitation of claims 7-9.
Regarding claims 10-12, although Sthalekar teaches that platelet-rich plasma comprises TGF-β1, Sthalekar does not further comment on the concentration of TGF-β1. However, Landesberg teaches measuring the concentration of TGF-β1 in the human PRP compositions for patients 1, 2 and 3 (Table 3), wherein the TGF-β1 concentrations for patients 1, 2 and 3 were 3.89 ng/3 mL, 4.97 ng/3 mL and 7.66 ng/3 mL, respectively, which correlates to 1.29 ng/mL, 1.66 ng/mL and 2.55 ng/mL, respectively (QUANTIFICATION OF TGF AND PDGF IN PRP PREPARATIONS, page 298).
Therefore, absent evidence to the contrary, it is reasonable to consider the platelet-rich GFC product of Sthalekar would have TGF-β1 concentrations ranging from 1.29 ng/mL to 2.55 ng/mL, thus meeting the limitation of claims 10-12.
Claim(s) 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sthalekar and Landesberg, as applied to claims 3-12 above, and further in view of Ho et al., (US 2006/0051731, see PTO-892) (“Ho”) and Andia et al., (International Journal of Molecular Sciences, 2020, 21, 6904, 18 pages; see PTO-892) (“Andia”), as evidenced by USGS, Water Density (June 5, 2018, 5 pages, retrieved from the internet; see PTO-892) (“USGS”).
The teaching of Sthalekar and Landesberg is set forth above.
Regarding claim 13, Sthalekar does not further teach the platelet-rich plasma GFC composition is further prepared as a freeze-dried powder, however Ho is directed to preparing freeze-dried platelets since doing so provides a long shelf-life to the product and the product can be used for all standard procedures, including in vivo therapies (Abstract) and Andia likewise teaches freeze-drying of platelet products preserves platelet function, cytokine concentration and functionality, and provides a standardized, off-the-shelf product with improved stability and readiness for future uses (Abstract).
Therefore, given the intention of Sthalekar is to provide platelet-based therapies to patients suffering from melasma, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare freeze-dried compositions since doing so permits advance preparation since the product has a long shelf-life with improved stability and readiness for future use.
The person of ordinary skill in the art would have been motivated to modify the method of Sthalekar, as taught by Ho and Andia, for the predictable result of successfully providing a standardized, off-the-shelf product with improved stability and readiness for future use, thus meeting the limitation of claim 13.
The skilled artisan would have had a reasonable expectation of success in combining the teachings of Ho and Andia with the cited prior art because each of these teachings are directed at therapeutic uses of compositions comprising platelets.
Regarding claim 14 and the claimed concentration of dry powder, it is noted as set forth above regarding claims 3-5, it is considered that the platelet-rich GFC product of Sthalekar would have platelet concentrations ranging from a minimum of 1.73 x 108/ml to as many as 9.35 x 108/ml.
Ho teaches that freeze-dried platelets containing less than 10% by weight of moisture, i.e., they have lost at least 90% of water weight ([0012]).
USGS evidences that 1 ml of water weights approximately 1 gram (Overview).
Therefore, the freeze-dried platelets of Sthalekar would comprise 1.73 x 108/ 0.1 gram to as many as 9.35 x 108/ 0.1 gram, which correlates to 17.3 x 108 per gram to 93.5 x 108 per gram. Thus, the claimed range overlaps the prior art range. 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). MPEP 2144.05
Regarding claim 15 and the claimed concentration of PDGF-BB, it is noted as set forth above regarding claims 7-9, it is considered that the platelet-rich GFC product of Sthalekar would have PDGF-AA/PDGF-BB concentrations ranging from a minimum of 0.63 ng/mL, to as many as 1.03 ng/mL.
Ho teaches that freeze-dried platelets containing less than 10% by weight of moisture, i.e., they have lost at least 90% of water weight ([0012]).
USGS evidences that 1 ml of water weights approximately 1 gram (Overview).
Therefore, the freeze-dried platelets of Sthalekar would have PDGF-AA/PDGF-BB concentrations ranging from 0.63 ng/0.1 gram, to as many as 1.03 ng/ 0.1 gram, which correlates to 6.3 ng per gram to 10.3 ng/ per gram. Thus, the claimed range overlaps the prior art range. 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). MPEP 2144.05
Regarding claim 16 and the claimed concentration of TGF-β1 it is considered the platelet-rich GFC product of Sthalekar would have TGF-β1 concentrations ranging from 1.29 ng/mL to 2.55 ng/mL.
Ho teaches that freeze-dried platelets containing less than 10% by weight of moisture, i.e., they have lost at least 90% of water weight ([0012]).
USGS evidences that 1 ml of water weights approximately 1 gram (Overview).
Therefore, the freeze-dried platelets of Sthalekar would have TGF-β1 concentrations ranging from 1.29 ng/0.1 gram to 2.55 ng/ 0.1 gram, which correlates to 12.9 ng per gram to 25.5 ng/ per gram. Thus, the claimed range overlaps the prior art range. 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). MPEP 2144.05
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 1-5 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-2 of copending Application No. 18/235597 (“copending ‘597”) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because copending ‘597 is directed to a platelet composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed. No claim is free of prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to E. YVONNE PYLA whose telephone number is (571)270-7366. The examiner can normally be reached M-F 9am - 6pm.
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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