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 3/21/25 has been considered by the examiner.
Status of the Claims
Claims 4-6, 9, 21, 24, 26-33, and 35-90 have been canceled by preliminary amendment. Claims 1-3, 7, 8, 10-20, 22, 23, 25, and 34 are pending and under current examination.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
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 1-3, 7, 8, 10-20, 22, 23, 25, and 34 are 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 1 recites “substantially” non-porous. The metes and bounds of this term are unclear, and the specification as filed does not provide a definition of what is included or excluded or how to ascertain what constitutes “substantially”. All claims depending from claim 1 require this limitation too and are also rejected here.
Claim 34 recites “at least about 10%”, however the term ‘about” is not defined in the specification as filed such that the “at least” terminology coupled with the “about” terminology obfuscates the endpoint of the claimed range. Ascertaining what values lie inside and/or outside the claimed range may vary from one skilled artisan to another absent a definition.
Appropriate clarification is required.
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 1-3, 7, 8, and 10-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0384163A1 (“Ali”) in view of US2022/0118416 (Pathak et al., “Pathak”).
The instant claims are drawn to a biomaterial [product] comprising a plurality of geometric elements and a therapeutic agent wherein (a) a first geometric element of the plurality of geometric elements comprises a first polymer and the therapeutic agent, wherein at least a portion of the first geometric element is porous; (b) a second geometric element comprising a second polymer, wherein at least a portion of the second geometric element is substantially non-porous.
Ali teaches a biomaterial for treating a condition wherein the biomaterial may be, for instance, a surgical article to be implanted for the treatment of cancer (see abstract, in particular). Ali’s biomaterial comprises a first plurality of geometric elements and a therapeutically-effective amount of a therapeutic agent, wherein this plurality is formed by a first porous border comprising a polymer; a second corresponding plurality is formed including a non-porous border in an adjacent region (see [0004]). The biomaterials may be comprised of polymer materials which may be bioresorbable and/or biodegradable or a mix thereof (see [0016]). The polymers may be polycaprolactone for instance in a blend (see [0044] and [0045]), and Ali demonstrates 6000 molecular weight PCL (polycaprolactone)(see [0106]) loaded with 30% by weight of the fluorouracil (see [0106]). Ali specifies the degree of porosity to be between 10 and 90% (see [0119]). Ali specifies 5-fluorouracil as a chemotherapy drug (limitation of claims 16, 18, and 19) which may be employed (see [0048]), and/or an antimicrobial active agent (limitation of claim 17) may be employed (see [0054], [0055], and [0056]).
While Ali teaches a polymer having a molecular mass of 6000 Daltons (Da), Ali does not teach a polymer necessarily having a number average molecular mass of greater than 6,000 Da as in claim 1.
Pathak cures this deficiency. Pathak teaches composite materials comprising biodegradable polymers for injectable compositions comprising composite microparticles or microspheres for controlled drug delivery for instance (see abstract, in particular). Pathak further specifies polymers of caprolactone to be among the polymers applicable (see [0091] and [0107]) wherein preferred polymers have molecular mass of preferably 1000 to 200,000 Daltons (see [0146]) specifically teaching PLGA with molecular weight of 10,000-15,000 Daltons (see [0125]).
Both Ali and Pathak are directed to polymeric biomaterials for delivering therapeutic agents, and both specify a biomaterial comprising polymers (see Ali at [0004] and PLGA and Pathak at [0286]). It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to increase the molecular mass of a polymer carrier component for drug delivery by substituting Pathak’s preferred PLGA polymer for instance for Ali’s generally disclosed polycaprolactone in order to increase the stability of the final product for instance by increasing melting point, tensile strength, or chemical resistance as a function of increased molecular mass for improved drug delivery properties. Moreover, regarding claims 2, 3, 7, 8, 10, and 11, one would have been motivated to do so regarding both first and second polymers (i.e., a hydrophilic and a hydrophobic for instance) in order to facilitate generally improved compatability and formula stabilization. Moreover, regarding claims 12-15, one would have been motivated to combine and/or substitute PLGA and polycaprolactone based on the combined disclosure of these polymers as desirably functional in composite materials for injectable compositions.
Claims 20, 22, 23, 25, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0384163A1 (“Ali”) in view of US2022/0118416 (Pathak et al., “Pathak”) as applied to claims 1-3, 7, 8, and 10-19 above, and further in view of JP2020075162 (“David”).
The teachings of Ali and Pathak have been delineated above. Neither of these specifies a quantitative amount of therapeutic agent as in claims 20, 22, 23, and 25 or a porosity parameter as in claim 34. Ali teaches a biomaterial comprising a plurality of geometric elements and a therapeutic agent (see [0004]) wherein a first geometric element comprises a first polymer and a therapeutic agent in an amount of 30% by weight of the first polymer which may be for instance polycaprolactone (see [0047]).
David cures this deficiency. David specifies that the therapeutic agent in the first geometric element is about 95%, an amount greater than Ali’s 30%. See last paragraph page 4/70 of David translation suggesting at last 70% of drug per tablet weight, for instance; see also weight ranges recommended on page 20/70 of translation.
Ali, Pathak, and David are all directed to biomaterials for delivering a therapeutic agent. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to increase the amount of therapeutic agent from Ali’s amount to David’s greater amount based on David’s demonstration of doing so with success. One would have been motivated to do so in order to provide more of a therapeutic agent for greater efficacy.
Further regarding claim 34, which depends from claim 20, Ali teaches a porosity of the first geometric element to at least or up to about 10%, a range including the claimed range (see [0028]). As to the method of ascertaining this feature, Pathak teaches scanning electron microscopy for monitoring polymer degradation in vitro (see [0304]).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AUDREA B CONIGLIO/ Primary Examiner, Art Unit 1617
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