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 .
Claims 1-11 are presented for examination.
Applicants’ drawings and preliminary amendment filed July 17, 2023 have been received and entered.
Applicants’ information disclosure statement filed August 7, 2023 has been received and entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 1-5 and 9-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating sialorrhea with a medicine comprising glycopyrronium salicylate or a solvate thereof, does not reasonably provide enablement for preventing sialorrhea with a medicine comprising glycopyrronium salicylate or a solvate thereof. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
In this regard, the application disclosure and claims have been compared per factors indicated in the decision In re Wands, 8 USPQ2d 1400 (Fed. Cir., 1988) as to undue experimentation.
The factors include:
1) the quantity of experimentation necessary
2) the amount of direction or guidance provided
3) the presence or absence of working examples
4) the nature of the invention
5) the state of the art
6) the relative skill of those in the art
7) the predictability of the art and
8) the breadth of the claims
The instant specification fails to provide guidance that would allow the skilled artisan background sufficient to practice that instant invention without resorting to undue experimentation in view of further discussion below.
The nature of the invention, state of the prior art, relative skill of those in the art and the predictability of the art
The claimed invention relates to a method for preventing sialorrhea with a medicine comprising glycopyrronium salicylate or a solvate thereof to said subject.
The relative skill of those in the art is generally that of a Ph.D. or M.D.
There are no known preventive therapies for sialorrhea (hypersalivation) in the art.
It is clear the art to which the present invention relates is highly unpredictable and unreliable with respect to conclusions drawn from laboratory data extrapolated to clinical efficacy.
The breadth of the claims
The claims are very broad and inclusive of any “causes” of sialorrhea.
The amount of direction or guidance provided and the presence or absence of working examples
There are no examples showing the instant compound, glycopyrronium salicylate or a solvate thereof will, in fact, prevent sialorrhea in a subject not presently at risk of or predisposed to developing such a disorder. No examples showing the instant compound is administered to a healthy subject not having sialorrhea, and the administration of the instant compound will prevent the subject from becoming afflicted with sialorrhea during its lifetime. Current modes of treatment are known, but there are no known agents, which can be, prevent the causes of sialorrhea in a healthy subject.
The quantity of experimentation necessary
Applicants have failed to provide guidance as to which cause would be prevented for sialorrhea. The skilled artisan would expect the interaction of a particular drug in the prevention of causes of sialorrhea to be very specific and highly unpredictable absent a clear understanding of the structural and biochemical basis of the agent. The instant specification sets forth no such understanding nor any criteria for extrapolating beyond the administration of the glycopyrronium salicylate or a solvate thereof. Even for the data presented, no direction is provided to prevent specific causes of sialorrhea. Absent reasonable a priori expectations of success, one skilled in the art would have to test extensively many conditions that may lead to sialorrhea to discover which cause is prevented. Since each prospective embodiment, as well as future embodiments as the art progresses, would have to be empirically tested, undue experimentation would be required to practice the invention as it is claimed in its current scope. The specification provides inadequate guidance to do otherwise.
Claims 1-5 and 9-11 are not allowed.
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 2-4 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 2 is rendered indefinite and vague by the phrase “the medicine is used so as to be affixed”. What does this phrase mean? What is the medicine affixed to? The skin.
The remaining claims 3 and 4 are rendered indefinite to the extent that they incorporate the above terminology.
Claims 2-4 are not allowed.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2020/020879 A1, hereby known as Abels et al.
Abels et al. teach medicine comprising at least one anticholinergic compound, wherein the one anticholinergic compound is glycopyrronium (GP) salts (see page 5, line 8). Note page 5, line 20, the salicylate salts. Note page 10, lines 4-7 teaches the medicine is applied topically. Also note page 10, lines 9-11 teaches the medicine can be topically application on the skin of a mammal for 1 time per day and most preferably 2-3 times per week (affixed once a day and be re-affixed every 24 hours (everyday).
Clearly, the cited reference teaches glycopyrronium salicylate salt is old and well-known in the art. The cited reference teaches a medicine or medicament comprising glycopyrronium salicylate is old and well-known and the application of the medicine or medicament to the subject is well-known too. Therefore, applicants’ instant glycopyrronium salicylate alone or in a medicine and/or medicament is anticipated by the cited reference. Note further that recitation of intended use does not further limit a claim drawn to a composition (a medicine is a composition).
Claims 1-4, 6 and 7 are not allowed.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-5, 7 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over WO 01/08681 A1, hereby known as Venkataraman, in view of WO 2020/020879 A1, hereby known as Abels et al.
Venkataraman teaches methods for administering transdermal glycopyrrolate compositions (see abstract). Note page 1, line 21 teaches the transdermal glycopyrrolate compositions are used to treat conditions such as sialhorrhea (sialorrhea). Note page 11, lines 12-15 teaches the transdermal administration includes a patch (a transdermal absorptive preparation). Note page 1, lines 27-33 teach the glycopyrrolate is an anticholinergic compound
The instant invention differs from the cited reference in that the cited reference does not teach the preferred active ingredient, glycopyrronium salicylate. However, the secondary reference, Abels et al., teaches glycopyrronium and its salts (see page 5, lines 14-29), includes salicylate salt. Note the application on the skin of a mammal for 1 time per day and most preferably 2-3 times per week (affixed once a day and be re-affixed every 24 hours (everyday).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute glycopyrronium salicylate for glycopyrrolate (glycopyrronium) in the treatment of sialorrhea with a predictable expectation of successful treatment due to the active ingredient’s structural and functional similarities.
Claims 1-5, 7 and 9-11 are not allowed.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Burton et al. (5,948,433) in view of WO 2020/020879 A1, hereby known as Abels et al.
Burton et al. teach a transdermal patch that includes a backing layer, a liner layer, and a monolithic adhesive (plaster) and drug-containing layer between the backing layer and the liner layer. Note the drug-containing adhesive layer includes a plasticizer (see the abstract).
The instant invention differs from the cited reference in that the cited reference does not teach the preferred active ingredient, glycopyrronium salicylate in the transdermal patch (a transdermal absorptive preparation). However, to use any active ingredient in a transdermal patch is old and well-known in the pharmaceutical art.
Claim 8 is not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/ Primary Examiner, Art Unit 1629