DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Acknowledgement is made of the response filed on September 25, 2025. In that response, claims 36-38 and 42 were amended. Claims 44-55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 January 25, 2025.
Claims 36-43 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 36 is objected to because of the following informalities: “a” or a similar article should precede the “low” and “high” molecular weight polymers. Appropriate correction is required.
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 36-43 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.
The terms “low molecular weight polymer” and “high molecular weight polymer” in claim 36 are relative terms which render the claims indefinite. The terms “low molecular weight polymer” and “high molecular weight polymer” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure states, “[t]he following aspects and embodiments thereof described and illustrated below are meant to be exemplary and illustrative, not limiting in scope” (para.0012 (emphasis added), pre-grant publication US 2023/0134250). In paragraph 0024, the disclosure states as follows.
In embodiments, the low molecular weight polymer has a molecular weight of between about 1-10 K Da. In further embodiments, the high molecular weight polymer has a molecular weight of between about 50-300 K Da. In additional embodiments, the high molecular weight polymer has a molecular weight of between about 50-70 K Da.
(para.0024, pre-grant publication US 2023/0134250). Because “embodiments” are only “exemplary and illustrative, not limiting in scope”, the disclosure in paragraph 0024 does not define “low molecular weight polymer” and “high molecular weight polymer”. None of the dependent claims resolves this issue and therefore all are also rejected on this ground.
For the purposes of examination now this claim term is construed as two polymers having different molecular weights.
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 36-43 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The “Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 ‘merely by clearly describing one embodiment of the thing claimed’.” MPEP §2163(II)(A)(3)(a)(ii) (citations omitted).
Claims 36 now recites “the polymer matrix including a ratio of low molecular weight polymer and the high molecular weight polymer of about 4:1”. It is noted for clarity that this means a ratio of LMWP: HMWP in a range of not precisely 4:1 but “about” 4 : 1. Applicant has disclosed one specific ratio wherein LMWP is greater than HMWP, at precisely 4:1 (pre-grant publication US 2023/0134250, Fig.7, paras. 0101, 0158, 0223). Applicant’s disclosure of LMWP: HMWP of precisely 4:1 related solely to two PLGAs and no other combination of a “water insoluble polymers” in claims 36-43. In other words, Applicant discloses only one instance in which a specific low molecular weight polymer, PLGA, is in a ratio of precisely 4:1 to another PLGA as the HMWP. The disclosure does not contain any discussion warranting the extrapolation of a single ratio actually disclosed, i.e., 4:1, to any other ratios encompassed by “about 4”. Furthermore the single disclosed instance involved both the LMWP and the HMWP being PLGA’s. The disclosure does not contain any discussion warranting the extrapolation of the two polymers to any water insoluble polymers. This is an instance where a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 ‘merely by clearly describing one embodiment of the thing claimed. The skilled artisan would not have considered the claimed range adequately supported by Applicant’s disclosure.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 36-43 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Singh (US 2011/0276028).
Singh teaches methods of making an array of microprojections comprising a parathyroid hormone (PTH) (title; abstract). Specifically “an array is prepared by (a) providing a mold with cavities corresponding to the negative of the microprotrusions, (b) filling the mold with a casting solution comprising a biocompatible material such as a biocompatible polymer and a solvent, ( c) removing the solvent, and ( d) demolding the resulting array from the mold” (para.0065 (emphasis added); see paras.0135-42; 0149).
In step (b), the “solution which is cast preferably comprises one or more polymers in a solvent and an active ingredient” (para.0068). Suitable biocompatible and biodegradable polymer includes PLGAs and PEG-PLGA block copolymers (paras. 0068-69, 0077, 0082) and suitable solvents include those in claims 39 and 40 (para.0083). Table 7-1 shows Examples D1 through D7 comprising a blend of PEG-PLGA 50/50 and 65/35, with human PTH (hPTH) as the drug (paras.0136-38). The PLGA’s having different ratios of 50/50 and 65/35 would have different molecular weights. “The polymers used may possess a variety and range of molecular weights”, such as “molecular weights of at least about 1 KD, …, or at least about 100 kD” (para.0073). Singh does not specifically teach the ratio of “about 4:1” in claim 36. However Singh teaches using PLGA for “sustained release” (para.0018, Example 7), wherein “hydrophobic segment(s) of the polymer are effective to control the release of drug substance” (para.0136). Optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted). Here, in the absence of a specific therapeutic agent, polymers, and the desired “sustained release” in the claims, the ratio of “about 4:1” is not seen as leading to any critical results.
The formulation of polymer and active agent is applied to a mold by spreading over the mold, the mold is pressurized, “the excess formulation is wiped”, and dried such as by placing in an incubator at 32 °C for about ½ or 1 hour (para.0121; see paras.0063, 0081).
A two-layer array is made by casting an additional layer or the backing, by placing a solution of PLGA in acetonitrile on the mold, casting a thin film “atop the first drug-containing formulation”, and dried (para.0125; Figs. 9A, 9B and accompanying text). Singh also teaches using an adhesive film (paras. 0121, 0151).
Singh does not expressly teach separately dissolving or suspending the active agent and the polymer, followed by mixing the two resulting solutions or suspensions as recited in claim 36.
However it would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to modify the teachings of Singh and separately dissolve or suspending the active agent and the polymer, followed by mixing the two resulting solutions or suspensions as recited in the instant claims. It has been held that making separable what was known in the prior art where removability or access was desirable, has been held to be obvious. See MPEP § 2144.04 (V)(C) (citations omitted). Furthermore “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”. MPEP §2144.04 (IV)(C)(citations omitted). Here the skilled person would have known to use separate solvents or medium for the active agent and the polymer, such as water and other solvents that Singh teaches (e.g., Example 3 pata.0124; see para.0083). Dissolving or suspending the active agent in its solvent and doing so separately for the polymer, and mixing the two before applying the components to the mold is thus prima facie obvious in the absence of new or unexpected results.
Regarding “to lower the initial release rate” and “to increase the initial release rate” in claim 40, it is noted that a clause that “simply expresses the intended result of a process step positively recited” in a method claim is not given weight. MPEP §2111.04(I)(citations omitted). Here whether the recited solvents actually attain the results would depend on factors such as the actual polymer used, the concentrations, etc.
Regarding claims 42 and 43, Singh teaches using an incubator at elevated temperatures, followed by drying the arrays (e.g., paras.0122, 125, 0142). Official notice is taken that convection ovens are used in dehydrating material by taking advantage of the circulating hot air within the oven. Here the claims do not recite any specific polymer, the active agent, or the dimensions of the microstructures that would indicate whether the recited temperature and durations would result in any unexpected results.
Response to Arguments
Applicant’s arguments with respect to claim(s) 36-43 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
CONCLUSION
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614