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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 9, 2025, that includes a response to the Final Office Action mailed October 9, 2024, has been entered. Claim 2 has been amended; claims 1, 4-12, and 17-22 have been canceled; and claims 24-26 have been newly added. Claims 13-16 have been withdrawn. Claims 2, 3, and 23-26 are under examination.
Withdrawal of Prior Claim Rejections - 35 USC § 112(b)
Claim 2 has been satisfactorily amended. Therefore, the 35 USC 112(b) rejection presented in the Final Office Action mailed October 9, 2024 is hereby withdrawn.
Claim Objections
Claims 2 and 26 are objected to because of the following:
i) In claim 2, there is a missing “the” between “at least 60% of” and “initial allergen content”.
ii) In claim 26, the expression “the biodegradable substance…are dissolved” is in improper English grammatical form.
Claim Rejections - 35 USC § 112(a)
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.
Claim 26 is 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.
Newly added claim 26 stipulates in a wherein clause that “at least 90% of the biodegradable substance that forms the plurality of the micro-needles are dissolved within 3 hours after the plurality of micro-needles are inserted into the skin”. Applicant states that “support for the…added claims appears in the specification and claims as originally filed”. The specification provides adequate support for “at least 90% of the micro-needles are dissolved in 3 hours” (see e.g. paragraph 0022) and for “approximately at least 90% of the dissolvable type micro-needle inserted within the skin had been dissolved approximately in 2 or 3 hours after the attachment” (see e.g. paragraph 0108). However, “at least 90% of the micro-needles are dissolved in 3 hours” is not one and the same as “at least 90% of the biodegradable substance that forms the plurality of the micro-needles are dissolved within 3 hours”. Indeed, e.g. 90% of the biodegradable substance could dissolve without 90% of the micro-needles dissolving. Even if each microneedle contained only the biodegradable substance, the biodegradable substance of each microneedle could be 90% dissolved, but not a single microneedle is completely dissolved, if “at least 90% of the microneedles are dissolved” means “at least 90% of the microneedles are 100% dissolved”. Hence, there is insufficient support in the original specification and claims for the subject matter of newly added claim 26.
This constitutes new matter.
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 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 2, 3, and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Quan et al. (U.S. Patent Application Pub. No. 2010/0228203), in view of Laulicht et al. (U.S. Patent Application Pub. No. 2014/0207105), and Biagtan et al. (Curr. Allergy Asthma Rep. 2014; 14(12): 482; pages 1-12).
Applicant Claims
Applicant’s elected subject matter is directed to a microneedle “patch” comprising a plurality of microneedles, wherein each microneedle is biodegradable and contains hyaluronic acid and house dust mite allergen in a “biodegradable substance” that forms the plurality of microneedles; wherein the house dust mite is the Dermatophagoides farinae species, wherein the allergen is contained in the microneedle patch in the amount of at least 10 µg, and wherein at least 90% of the biodegradable substance that forms the plurality of micro-needles dissolves within 3 hours after the plurality of microneedles are inserted into the skin.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Quan et al. disclose a microneedle device that can be easily inserted into skin comprising a plurality of microneedles and a substrate (i.e. a base); wherein each microneedle is biodegradable, contains hyaluronic acid and a pharmaceutical agent, e.g. an antigen, and dissolves in the skin after application thereto (abstract; paragraphs 0008, 0010, 0011, 0018, 0025-0028, 0035, 0042, 0052, 0053).
Laulicht et al. disclose a microneedle device to induce antigen tolerance in a subject comprising a plurality of microneedles and a support (i.e. a base); wherein e.g. each microneedle is biodegradable and contains an allergen, and the allergen can be e.g. a house dust mite allergen (e.g. D. pteronyssinus) (abstract; paragraphs 0012, 0023, 0024, 0045, 0069, 0070, 0072).
Biagtan et al. disclose that D. farinae, like D. pteronyssinus, is a major species of house dust mite that are ubiquitous and which cause allergy and asthma in subjects by the allergens Der f1 and Der f2, and that for subcutaneous immunotherapy of dust mite-induced allergy and asthma, which involves administration of allergic extracts to a subject by injection into the dermal tissue, the therapeutic dose of dust mites is 500-2000 AU for a dose of 10 µg of Der f1.
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Quan et al. do not explicitly disclose that the antigen is a house dust mite allergen of the D. farinae species, and that the allergen is contained in the microneedle patch in the amount of at least 10 µg. These deficiencies are cured by the teachings of Laulicht et al. and Biagtan et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Quan et al., Laulicht et al., and Biagtan et al., outlined supra, to devise Applicant’s claimed microneedle patch.
Quan et al. disclose a microneedle device that can be easily inserted into skin comprising a plurality of biodegradable microneedles and a substrate (i.e. a base); wherein each microneedle is biodegradable, contains hyaluronic acid and a pharmaceutical agent, e.g. an antigen, and dissolves in the skin after application thereto, and thus delivers the antigen to the skin. Since Laulicht et al. disclose that a microneedle device comprising a plurality of biodegradable microneedles and a support (i.e. a base); wherein e.g. each microneedle is biodegradable and contains an allergen, and the allergen can be e.g. a house dust mite allergen (e.g. D. pteronyssinus), can be employed to deliver the house dust mite allergen to the skin for inducing tolerance; and since Biagtan et al. disclose that D. farinae, like D. pteronyssinus, is a major species of house dust mite that are ubiquitous and whose allergens cause rhinitis and asthma in subjects by the allergens Der f1 and Der f2, and that for subcutaneous immunotherapy of dust mite-induced allergy and asthma, which involves administration of allergic extracts to a subject by injection into the dermal tissue, the therapeutic dose of dust mites is 500-2000 AU for a dose of 10 µg of Der f1; one of ordinary skill in the art would thus be motivated to employ a house dust mite allergen of the D. farinae species, e.g. Der f1, as the antigen in the Quan et al. microneedle device, wherein the said allergen is contained in the microneedle device in the amount of at least 10 µg, with the reasonable expectation that the house dust mite allergen of the D. farinae species, e.g. Der f1, can be successfully delivered to the skin to induce tolerance.
One of ordinary skill in the art, in following the express teachings and reasonable suggestions of the cited prior art, would thus arrive at a microneedle patch that can be easily inserted into skin comprising a plurality of biodegradable microneedles composed of hyaluronic acid and a house dust mite allergen of the D. farinae species, which plurality of microneedles dissolve in the skin after application thereto. Since the microneedles are the same as those claimed, the properties must be the same as well, including the property that at least 90% of the plurality of microneedles are dissolved in 3 hours after the plurality of microneedles are inserted into the skin.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed April 9, 2025 have been fully considered but they are not found persuasive:
i) Applicant contends that the cited prior art does not “teach or suggest…wherein at least 60% of initial allergen content remains at a period of 8 weeks after the micro-needle patch is produced”; that “due to the selection of a particular biodegradable substance that forms the micro-needles as well as the specific physical structure of the micro-needles, the claimed micro-needle patch provides significantly improved stability for the allergen contained in the biodegradable substance”; that “in FIG. 9, the concentration changes for (i) allergen left at room temperature…(ii) allergen maintained at 4C…and (iii) allergen contained in the claimed micro-needle patch and maintained at 4C…are compared” and “the allergen content of the claimed micro-needle patch decreases at a significantly slower rate” and thus “it is evident that the microneedle configuration provides a more substantial stabilizing effect”.
The Examiner, however, would like to point out the following:
1. One of ordinary skill in the art, in following the teachings and reasonable suggestions of the cited prior art, would arrive at the claimed microneedle patch. Since the microneedle patch is the same, the properties must be the same as well. In general terms, if the prior art discloses a microneedle patch wherein each microneedle is biodegradable and comprises e.g. hyaluronic acid and an allergen, Applicant cannot patent or re-patent a microneedle patch wherein each microneedle is biodegradable and comprises e.g. hyaluronic acid and an allergen, merely because Applicant has documented a property of the product presumably kept in storage, and under an undefined set of conditions.
2. Quan, the cited primary reference, discloses a microneedle device that can be easily inserted into skin comprising a plurality of microneedles; wherein each microneedle is biodegradable, contains hyaluronic acid (i.e. the biodegradable substance) and e.g. an antigen, and dissolves in the skin after application thereto. In other words, Quan already has the microneedles and the hyaluronic acid. If, as Applicant contends, the property at issue here is due to the microneedle structure and the particular biodegradable substance that forms the micro-needles, i.e. hyaluronic acid, then Quan already provides these critical elements. It can only be concluded that Quan has the recited property as well.
3. Hence, Applicant’s showing that the allergen is more stable during storage in the microneedles composed of hyaluronic acid compared to allergen not in microneedles is obviously not sufficient to overcome the rejection. Rather, Applicant’s data merely demonstrates a property of the Quan microneedle device. If “the microneedle configuration provides a more substantial stabilizing effect”, then the Quan microneedle product would no doubt have this property. In the United States, the product itself must be new and non-obvious if Applicant wants a U.S. patent for the product. It is not enough to simply demonstrate a property of a prior art product, even if the prior art does not expressly disclose the property. Applicant has not provided any hard evidence of any kind whatsoever that the Quan product does not have the recited property. On the contrary, because Quan has the allergen in microneedles composed of hyaluronic acid, all the essential features required for the property, one can only conclude that the property is there, absent evidence to the contrary.
4. Moreover, it is noted that the requisite storage conditions during the 8-week period after the micro-needle patch is produced are undefined. The claims place no limits whatsoever on the temperature at which the microneedle product is stored during the 8-week period. Hence, Applicant’s comparison of the allergen stability at room temperature vs 4C is merely comparing one temperature within the scope of the claims vs another temperature within the scope of the claims.
5. Again, since the product one of ordinary skill in the art would thus arrive at is the same as the claimed product, the properties must be the same. Applicant has provided no hard evidence to the contrary, and Applicant cannot simply render “non-obvious” an obvious product merely by documenting a property of that product. Moreover, just because a prior art reference does not disclose a particular property does not mean that it does not actually have that property in the real world. Applicant has not shown that their claimed product has a property that the Quan product does not have. There is simply no patentable advance here. Microneedle patches of the type as claimed have generally been known for decades upon decades. Biodegradable microneedles are generally well known. Biodegradable microneedles composed specifically of hyaluronic acid are well known, as is the fact that these hyaluronic acid microneedles rapidly dissolve when injected into skin. Employing microneedle patches to deliver therapeutics and allergens to skin is well known. House dust mite has long been known as an allergen for many decades. Delivering house dust mite as an allergen to skin via a microneedle patch is known. Applicant’s claimed subject matter is simply the work of the ordinary mechanic in the art.
For the foregoing reasons, the 35 USC 103 rejection is hereby maintained.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617