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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1 – 2, 5 – 6, 8, 10, 13 – 14, 29, 31 and 33 in the reply filed on December 8, 2025 is acknowledged. The traversal is on the grounds that the groups have unity of invention since all groups require a botulinum toxin that is administered in conjunction with an anticholinergic and that administering the agents exhibit enhanced efficiency when administered together. This is not found persuasive because the product claim of two actives does not make a contribution over the prior art, as supported by the rejections below.
The requirement is still deemed proper and is therefore made FINAL.
Applicant is reminded that non-elected claims may be considered for rejoinder when all claims directed to the elected invention are in condition for allowance. In order to be eligible for rejoinder, a claim to a nonelected invention must depend from or otherwise require all the limitations of an allowable claim. In order to retain the right to rejoinder, applicant is advised that the claims to the nonelected invention(s) should be amended during prosecution to require the limitations of the elected invention. Failure to do so may result in a loss of the right to rejoinder. MPEP 821.04
Claims 4 and 12 are canceled; claim 33 is added; claims 1 – 2, 5 – 6, 8, 10, 13 – 16, 19 – 24, 26, 29 and 31 – 33 are pending; claims 15 – 16, 19 – 24, 26 and 32 are withdrawn; claims1 – 2, 5 – 6, 8, 10, 13 – 14, 29, 31 and 33 have been considered on the merits.
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 – 2, 5 – 6, 8, 10, 13 – 14, 29, 31 and 33 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 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.
Amended claim 1 recites a “pharmaceutical composition product” comprising “a first pharmaceutical formulation container” and “a second pharmaceutical container” that are “separately packaged” which is not described in the specification as originally filed. The specification teaches methods of administering botulinum toxin (botox) followed by an anticholinergic as well as a composition comprising botox in combination with an anticholinergic (examples, original claim 1). However, the specification is silent on a “composition product” (i.e., a kit) or a “container” comprising these actives “separately packaged.” This is a new matter rejection.
Claim 1 additionally recites “at least four unit doses” of an anticholinergic which is not described in the specification as originally filed. The specification describes doses and units of botulinum toxin however is silent on units or doses with regards to anticholinergics. The examples disclose administering an anticholinergic in the form of a transdermal patch where 1 – 2 patches are applied every three days amounting to about 1 mg of scopolamine, or orally with no indication of units or dosage. However, none of the examples describe “at least four unit doses.” This is a new matter rejection.
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 – 2, 5 – 6, 8, 10, 13 – 14, 29, 31 and 33 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 and its dependents are drawn to a composition however are rendered vague and indefinite for reciting “the glands” as the phrase lacks proper antecedent basis. It is unclear to what and whose glands are being referenced.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 – 2, 5 – 6, 8, 10, 13 – 14, 29, 31 and 33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Step 1: Yes, the claims are drawn to a composition comprising botulinum toxin in a container, which is a composition of matter.
Step 2A, Prong 1: Yes, the claims are directed to a botulinum toxin, which is a product of nature or a natural phenomenon.
Step 2A, Prong 2: No, the claims do not recite additional elements that integrate the toxin into a practical application. Although claim 1 recites the toxin is in a container which is then set in the same location as another, separate composition (e.g., in a kit), neither the location of the botulinum toxin nor the placement of the toxin into a kit with other separate non-natural products results in a markedly different characteristic of the toxin itself (MPEP 2106.04(c)(I)(A)). The naturally occurring counterpart to the claimed botulinum toxin is the toxin obtained from Clostridium botulinum. Both the claimed toxin and its natural counterpart exhibit the same biological function of the neurotoxic protein, which is to prevent the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction, thus causing flaccid paralysis (Wikipedia Entry). Applicant indicates the term is generic for the family of toxins produced by the bacterium Clostridium botulinum (para. 0011 of the published application), indicating no specific properties of the toxin are altered from its natural counterpart and no new function is exhibited as a result of placing the toxin into a container.
Claims 1 and 31 additionally recite intended uses of the toxin, however these recited uses do not markedly change the toxin or integrate the toxin into a practical application because no active method steps are carried out and the claimed results are merely reciting effects of the natural product. Claims 5 – 6, 8, 10 recite specific amounts of the toxin, however these amounts do not markedly change the characteristics of the natural product as no new or altered function is disclosed or demonstrated as compared to its natural counterpart.
Step 2B: No, the claims do not recite additional elements that amount to more than the judicial exception. Claim 1 recites the toxin is in a container which is then placed alongside a second container comprising a different composition as in a kit, and intended uses of the composition. However, these limitations are merely generally linking the use of the botulinum toxin to a particular technology, e.g., pharmaceuticals, or field of use, e.g., preventing radiation damage. Moreover, these limitations are merely describing how the natural product could be used in the medical field (MPEP 2106.05(I)(A)).
Claims 5 – 6, 8, 10 recite specific amounts of the toxin, however these doses do not amount to significantly more than the toxin as they fail to contribute to an inventive concept since various units of botulinum toxin were commonly used in the art (see prior art cited in the rejections that follow).
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 5, 6,13, 14, 29, 31 and 33 are rejected under 35 U.S.C. 102a1 as being anticipated by Dessy et al. (2007, IDS filed 11.22.2024 NPL #11).
Regarding claims 1 – 2, 5 – 6, 13 -14, 29, 31 and 33, Dessy teaches pharmaceutical composition products comprising (a) 100 U of botulinum toxin A (BTX-A) injection, i.e., in a syringe or first container; and (b) a transdermal patch comprising scopolamine, i.e., in a patch or second container (p.950 - 951). The patches are replaced every 48 – 72 hours (2 – 3 days) for 18 days, indicating 6 – 9 patches, or at least 4 unit doses. The actives (BTX-A, scopolamine) are packaged separately, e.g., syringe and patch, and are administered sequentially (p.951). Since the BTX-A is in the claimed range of 1 – 1500 units, it must also meet the claimed “therapeutically effective amount.”
Dessy does not teach the intended use of the products, e.g., to be administered to prevent radiation damage to the seromucous glands, to be administered prior to and/or subsequent to diagnostic imaging or radiological treatments, or wherein the BTX-A downregulates alpha-1 adrenoceptors. However, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Regarding the activity of the BTX-A recited in claim 31, since the active of the prior art is the same as claimed and is in the same amount, it would inherently act to down regulate alpha-1 adrenoceptors since they are the same compositions.
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.
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 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Dessy et al. (2007, IDS filed 11.22.2024 NPL #11) in view of Racette (2003).
Regarding claim 1, Dessy teaches pharmaceutical composition products comprising (a) 100 U of botulinum toxin A (BTX-A) injection, i.e., in a syringe or first container; and (b) a transdermal patch comprising scopolamine, i.e., in a patch or second container (p.950 - 951). The patches are replaced every 48 – 72 hours (2 – 3 days) for 18 days, indicating 6 – 9 patches, or at least 4 unit doses. The actives (BTX-A, scopolamine) are packaged separately, e.g., syringe and patch, and are administered sequentially (p.951). Since the BTX-A is in the claimed range of 1 – 1500 units, it must also meet the claimed “therapeutically effective amount.”
Dessy does not teach the intended use of the products, e.g., to be administered to prevent radiation damage to the seromucous glands or to be administered prior to and/or subsequent to diagnostic imaging or radiological treatments. However, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Regarding claim 8, Dessy does not teach the pharmaceutical products wherein the botulinum toxin is BTX-B. However, Dessy teaches the BTX-A is administered for the purpose of increasing anticholinergic effects of scopolamine (p.951) and for the effect of treating scialorrea (p.950). At the time the claims were filed, BTX-B was known to exhibit antisialorrhea effects. In support, Racette teaches administering 1,000 units of BTX-B for improving sialorrhea (p.1059). As such, in following the teachings of Dessy, it would have been obvious to one of ordinary skill in the art to substitute 1000 units of BTX-B for the BTX-A of Dessy with a reasonable expectation for successfully treating parotid fistula with the same and predictable result.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims 1 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Dessy et al. (2007, IDS filed 11.22.2024 NPL #11) in view of Taylor (US 2006/0018931).
Regarding claim 1, Dessy teaches pharmaceutical composition products comprising (a) 100 U of botulinum toxin A (BTX-A) injection, i.e., in a syringe or first container; and (b) a transdermal patch comprising scopolamine, i.e., in a patch or second container (p.950 - 951). The patches are replaced every 48 – 72 hours (2 – 3 days) for 18 days, indicating 6 – 9 patches, or at least 4 unit doses. The actives (BTX-A, scopolamine) are packaged separately, e.g., syringe and patch, and are administered sequentially (p.951). Since the BTX-A is in the claimed range of 1 – 1500 units, it must also meet the claimed “therapeutically effective amount.”
Dessy does not teach the intended use of the products, e.g., to be administered to prevent radiation damage to the seromucous glands or to be administered prior to and/or subsequent to diagnostic imaging or radiological treatments. However, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Regarding claim 10, Dessy does not teach the method using botulinum toxin E or F (BoNT-E, BoNT-F). However, Dessy teaches the BTX-A is administered for the purpose of increasing anticholinergic effects of scopolamine (p.951) and for the effect of treating scialorrea (p.950). At the time the claims were filed, BoNT-E and BoNT-F were known to exhibit antisialorrhea effects. In support, Taylor teaches therapeutic compositions comprising BoNT-E or BoNT-F as alternatives to BoNT A or B wherein they are useful for treating sialorrhea and parotid fistula (0080, 0089, claim 33). As such, in following the teachings of Dessy, it would have been obvious to one of ordinary skill in the art to substitute 1000 units of BoNT-E or BoNT-F for the BTX-A of Dessy with a reasonable expectation for successfully treating parotid fistula and with the same predictable result.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699