--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 .
Applicant’s response dated December 23, 2025 is acknowledged.
Priority
This application is a continuation of 16/104,517 dated 08/17/2018, which claims benefit in provisional application 62/546,893 filed on 08/17/2017.
Claim Status
Claims 21-29 are pending. Claims 1-20 were canceled. Claims 24-29 are withdrawn. Claims 21-23 are examined.
Election/Restriction
Applicant’s election without traverse of Group I (Claims 21-23), drawn to an electrospun polymer sheet in the reply filed on December 23, 2025, is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 24-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being withdrawn to a non-elected invention, and non-elected species of the invention, there being no allowable generic or linking claims.
Response to the restriction requirement of October 28, 2025 was timely filed.
Claims 21-23 are examined on the merits.
Information Disclosure Statement
Foreign document cited under number 26, in the 26 page IDS dated August 10, 2023, was not considered because applicant did not provide a copy of the document. It is noted that the document has the same WO number as citation number 25, but a different publication date.
Non-patent literature documents cited under numbers 2 and 3, in the 8 page IDS dated August 10, 2023, were not considered because applicant did not provide a copy of these documents.
In the 8 page IDS dated August 10, 2023, the citation of non-patent literature document under number 6 was amended because the document is 7 pages long and not 9 pages; and the citation of non-patent literature document under number 9 was amended because the document is 15 pages long and not 11 pages.
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.
Claim 23 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 23 depends from claim 21 and requires the pharmaceutical to be in the form of an oil, a crystal, or a combination thereof. Claim 21 is a product by process claim that describes forming a plurality of fibers by electrospinning a solution of poly(ethylene oxide) and a pharmaceutical. Claim 23 is indefinite because it is not clear if “the pharmaceutical” refers to the pharmaceutical prior to being placed in solution and electrospinning or when it is in the fibers obtained by the electrospinning.
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 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Ignatious (US 2003/0017208 A1 Published January 23, 2003) as evidenced by Ying (Cardiovascular Research, 2009, 83, 155-162).
The claim encompasses an electrospun polymer sheet.
The teachings of Ignatious are related to electrospun pharmaceutical compositions (Abstract). Electrospinning is a process for producing fibers with diameters in the range of 100 nm (paragraph 0031). The pharmaceutical composition comprises an active agent(s) and a pharmaceutically acceptable polymer as an electrospun fiber. The homogenous nature of this process produces a quantity of fibers which allow for nanoparticles of drugs to be dispersed throughout (paragraph 0036). Preferred polymer includes polyethylene oxide such as the brand name POLYOX® (paragraph 0059). Drugs include vasodilators (paragraph 0044). The fibers may be cut and processed as a sheet for further administration with agents to form a polymeric film, which may be quick dissolving (paragraph 0083). Example 1 teaches a method of electrospinning of 25 % (w/w) aspirin composition. A stock solution of 2.5% of POLYOX WSR N-60KTM was prepared in water. Ten milliliters of this solution was added to a solution of 0.12g acetylsalicylic acid in 0.5 mL acetone. The contents were mixed and 1 mL acetone was added to obtain a clear solution. The solution was electrospun according to the example and dry fibers were collected on a drum and peeled off the drum (paragraph 0087).
Regarding claim 21, the example does not state the average diameter of the fibers, however it would have been prima facie obvious to a person skilled in the art before the effective filing date of the claimed invention to have formed the fibers in example 1 to have a diameter of 100 nm with a reasonable expectation of success because Ignatious teaches that electrospinning is a process for producing fibers with diameters in the range of 100 nm. It would have been further obvious to have formulated the fibers into a sheet intended for oral administration because Ignatious teaches the fibers may be formulated into a sheet and teaches administering the fibers orally.
The claimed invention is obvious over modified Example 1 because the modified example teaches an electrospun polymer sheet comprising a plurality of fibers electrspun from a solution comprising poly(ethylene oxide) and aspirin. It would have been reasonable to expect aspirin to be dispersed throughout the plurality of fibers because the fibers were formed from a solution where the polymer and the aspirin were homogeneously mixed. As evidenced by Ying, aspirin is a vasodilator (Abstract and Introduction). The fibers were produced by combining a 10 mL solution of 2.5% polymer with 0.12g of aspirin. The polymer solution contains 0.25g of the polymer. The concentration of aspirin relative to the polymer is 0.12g/0.25g*100 or 48% by weight. The claimed concentration range is obvious because it encompasses 48 wt. %. The average diameter range is obvious because it encompasses 100 nm.
Claim 23 is indefinite because it is unknown if applicant intended to limit the pharmaceutical by oil form and crystal form prior to electrospinning or in the finished product. It is known that aspirin is a solid. A solid is either crystalline or amorphous. Ignatious does not state whether or not aspirin is in crystalline form prior to electrospinning or in the dry fibers. It would have been reasonable to expect the fibers to contain solid aspirin because the fibers are described as dry, and it would have been reasonable to expect the aspirin to be in crystalline or amorphous form because aspirin is a solid and it necessarily exists in crystalline and/or amorphous form. Alternatively, if the applicant intended to limit the pharmaceutical by its form prior to electrospinning, such embodiment would have been obvious over Ignatious because the claims are product by process claims and the physical form of aspirin prior to electrospinning would have been irrelevant. The 0.12g of aspirin prior to processing would have been either crystalline and/or amorphous and either form would have been equally obvious. The specification was reviewed and there is no evidence that the form the vasodilator prior to processing is critical.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ignatious and Ying as applied to claims 21 and 23 above, and further in view of Pearce (US 2004/0247746 A1 Published December 9, 2004) as evidenced by Roman (US 2011/0229446 A1 Published September 22, 2011).
Claim 22 further defines the dimensions of the polymer sheet.
The teachings of Ignatious are relied upon as summarized above. They do not teach dimensions that are suitable for quick dissolving polymer sheets.
The teachings of Pearce are related to orally soluble films intended to carry medications and have a pleasant taste (Abstract). Medications include aspirin (paragraph 0122). Film may be in any desired thickness, length, or width. For example, the thickness may range from less than about 0.0005 inches to more than about 0.1 inches. The length and width may be chosen so that the film fits on a human tongue with or without folding, such as less than about 1.5 inches in width or length (paragraph 0175).
It would have been obvious to have formed Ignatious quick dissolving sheets intended for oral administration because Ignatious teaches that fibers may be formulated as a quick dissolving sheet intended for oral administration. Ignatious does not teach suitable dimensions of sheets, and it would have been obvious to have formed the sheets to easily fit the human tongue and have a width and length of less than 1.5 inches and a thickness in the range of 0.0005-0.1 inches, with a reasonable expectation of success because Pearce teaches thin films for oral administration where the thin film has dimensions suitable for placement on the tongue where the thickness is in the range of 0.0005-0.1 inches (equivalent to 0.0127-2.54 mm), and length and width in the range of less than 1.5 inches (equivalent to less than 38.1 mm). The selection of known dimensions based on their suitability for their intended use supports obviousness. The claimed length range is obvious because it overlaps with the range that spans less than 38.1 mm. The claimed width range is obvious because it overlaps with the range that spans less than 38.1 mm. The claimed thickness range is obvious because it overlaps with 0.0127-2.54 mm. The specification was reviewed and there is no evidence that claimed dimension ranges are critical.
Combining prior art elements according to known methods to obtain predictable results supports obviousness.
Alternative rejection for claim 23, it would have been obvious to have formed Ignatious’ sheet with a flavoring agent in a concentration of 0.1-30 wt. %, with a reasonable expectation of success because Ignatious teaches that the electrospun composition further comprises a flavoring agent (paragraph 0079). It would have been obvious to have selected peppermint oil as the flavoring agent with a reasonable expectation of success because it was known from Pearce that peppermint oil is useful as a flavoring agent in thin oral films intended for delivering a drug such as aspirin (paragraph 0045) where the flavoring agent is present in a concentration of 0.1-30 wt. % (paragraph 0046). As evidenced by Roman, peppermint oil is a vasodilator (paragraph 0021). Ignatious’ composition modified to contain 0.1-30 wt. % peppermint oil renders the claimed invention obvious because peppermint oil is a known vasodilator and it is an oil. Therefore, incorporating peppermint oil would have met the claimed embodiment that requires the pharmaceutical to be in the form of an oil. It would have been reasonable to expect peppermint oil to remain in the form of an oil after electrospinning into a fiber. Ignatious’ fiber contains 0.25 g of polymer and 0.12 g of aspirin, thus adding up to 30 wt. % peppermint oil would added up to 0.111 g of peppermint oil, which is about 44 wt. % relative to the weight of the polymer.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alma - Pipic whose telephone number is (571)270-7459. The examiner can normally be reached M-F 9:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALMA PIPIC/Primary Examiner, Art Unit 1617