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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/26/2024 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 04/24/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/24/2026.
Claims 1-12 are being examined on the merits.
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 1-12 are ejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating specific tissue diseases such as intervertebral disc and bacterial dysbiosis, however does not reasonably provide enablement for “preventing” or treating any tissue disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: Claim 1 recites a method of treating, preventing or ameliorating a tissue disease in a subject through the administration of a PRP composition. There is no required specific administration route and if taken orally it could be expected that the subject would vomit up the composition or it could be destroyed by enzymes and the high pH of the stomach. First pass metabolism could destroy the composition before it would even reach the specific tissue.
The state of the prior art: It would not be expected that a PRP composition would prevent any tissue disease. The body has many tissues all of which are different and there are no currently known preventions for all tissue diseases. This would be a monumental discovery and would dramatically change the medical industry. Prevention when take with the broadest reasonable interpretation would mean to stop from happening and this composition would not be expected to prevent Alzhiemer’s, Parkinson’s or ALS which are all tissue diseases.
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: The art is unpredictable as there are not many recorded preventative compositions for many neurological tissues, let alone other tissues of the body.
The breadth of the claims. The scope of the claims are broad in the sense that there are no administration routes and dosage amounts that tie the administration to the activity noted in the specifications. It is also noted that there is no specific definition of the term “preventing” in the specifications, so it is given its broadest reasonable interpretation of stopping something from happening or arising. The applicant claims a concentration of components in the composition but not the concentration of the composition to be administered which is important to note.
The amount of direction or guidance presented: The specification speaks to treating bacterial dysbiosis and intervertebral disc regeneration however this does not enable any person of skill to make and use the composition in a manner to treat other tissue diseases such as autoimmune disorders, neurological disorders, psychological, etc. There are over 200 known connective tissue disorders alone and this composition does not enable one to treat any of those diseases. There would need to be considerable guidance on how to make and use the PRP composition for preventing and treating any tissue because each tissue and disease is different requiring different concentrations of treatment, administration routes, modes of treatment and treatment plans, etc.
The presence or absence of working examples and the quantity of experimentation necessary: The specification provides working examples for the treatment of bacterial dysbiosis and intervertebral disc regeneration but that does not enable for any tissue disease. There would need to be considerable amounts of experimentation to determine which tissue diseases could be prevented let alone treated with the claimed composition. The applicant has not provided data and any examples that would enable persons skilled in the art to use the invention for preventing and treating any tissue disease.
Therefore, in view of the Wands factors, as discussed above, Applicants fail to provide information sufficient to practice the claimed invention for preventing any tissue disease.
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.
Claims 1-12 are ejected 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 1 recites “platelets at a concentration of at least 5 × to at least 75 × the concentration of platelets in whole blood” and “nucleated cells at a concentration of at least 5 × to at least 75 × the concentration of nucleated cells in whole blood” and these are relative amounts as each individual would be expected to have varying amounts of platelets and nucleated cells. Is this amount to a standardized “whole blood” or to the subject’s own whole blood prior to administration? This makes the limitation unclear and indefinite.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Silvia Erratico and Massimo Orlandi (EP4114416A1) and Meredith Prysak et. al. (From IDS, Optimizing the Safety of Intradiscal Platelet-Rich Plasma in Vitro Study with Cutibacterium Acnes, Regenerative Medicine, Vol 14, 2019 -Issue 10).
Regarding claim 1-2, Prysak teaches a platelet-rich plasma PRP, platelet-rich, PR, ≥10X enrichment and leukocyte-rich, LR, ≥10X enrichment composition (see 3rd para. page 956) and teaches the leukocytes to be lymphocytes and monocytes (see table 2, or results, last para. page 958).
Regarding claims 4-5, Prysak teaches “all experimental arms containing whole blood or whole blood-derived product recovered statistically significantly less CFU/ml of C. acnes than the negative control at the 24- and 48-h time points” (see 2nd para. page 960).
Regarding claims 6-8, Prysak teaches “the most common risk associated with intradiscal injection of platelet-rich plasma (PRP) is discitis with Cutibacterium acnes. It is hypothesized that antimicrobial activity of PRP can be enhanced through inclusion of leukocytes or antibiotics in the injectate” (see abstract).
Regarding claim 3, Prysak teaches “animal studies consistently demonstrate that the injection of PRP locally at the site of damage has the potential to slow the progression of disc degeneration ([2]; reviewed in [3]). These results have also been validated in the clinic, with sustained improvement in function and pain scores sustained for at least 2 years of follow-up [4, 5]” (see page 955, 1st para.).
“Furthermore, it is apparent that C. acnes is also an underappreciated pathogen of interest for regenerative medicine techniques involving the spine, such as the intradiscal injection of autologous biologics. Our recent cases of spondylodiscitis after the switch to a leukocyte-poor PRP preparation also raised the question of whether leukocyte exclusion was related to the increasing prevalence of infection we observed, and likewise whether a leukocyte-rich preparation would have a measurable antimicrobial effect against a pathogen such as C. acnes in the presence of biologics such as PRP” (see 1st para. page 956).
Regarding claims 9-10, Prysak teaches the PRP preparations are from whole blood and from subject’s own blood (see experimental design & study arms, page 956).
Regarding clams 11-12, Prysak teaches each experimental group was split into two arms: an antibiotic-=free arm and its paired arm containing a clinically relevant does of cefazolin (see experimental design & study arms, page 956).
Prysak does not specifically teach administration of the composition, however teaches that the study was conducted in order to elucidate whether a PRP-enriched, leukocyte-enriched composition could potentially help reduce C. acnes infections intended for persons undergoing intradiscal injections of platelet-rich plasma. Therefore, it would have been obvious to persons having ordinary skill in the art before the effective filing date to administer the composition described by Prysak as a method of treating, preventing or ameliorating a tissue disease in a subject because Prysak teaches that PRP-enriched and leukocyte-enriched compositions injected intradiscally are intended for regenerative medicine involving the spine. It would have also been obvious to administer the composition with an antibiotic as this would assist in clearing bacterial infections.
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 BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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