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
Election/Restriction
Applicant did not explicitly elect Group of invention in the reply on 12/12/2025. Group II invention previous drawn to composition or therapeutical agent gel for ablation of tissue are amended to recite a method for treatment of tissue beyond a superficial level, depending on claims 41 and 48 of Group I.
Instant application contains claims directed to more than one species of the generic invention and the Examiner requires to elect ONE single species, respectively, for 1) therapeutic agent; 2) thickening agent; 3) target superficial layer/ tissue.
Applicant elects species 3, target superficial layer/tissue with traverse. Applicant argues the election of species requirement is improper, “The invention as defined in the independent claims has a composition of a therapeutic agent and a thickening agent to target tissue beyond the superficial layer. Applicant does not see how these can be considered separate inventions”.
Applicant’s argument is NOT persuasive. Please note the species election requirement is NOT to elect between therapeutic agent, thickening agent and target superficial layer/ tissue. The election requirement is to elect ONE single species for each genus of therapeutic agent, thickening agent, and superficial layer/ tissue, respectively for search and examination purpose. The Restriction Requirement is still deemed proper and made Final.
Since the Applicant didn’t not elect species as required, the Examiner searched and examined trichloroacetic acid as the therapeutic agent, Carbopol® as the thickening agent, uterine endometrium recited in claim 47 as the superficial layer species. Claim 69 directed to epidermis around eyelids is preliminarily objected to because they do not read on uterine endometrium or related superficial layer.
Status of Claims
Claims 41-48, 50, 61-62, 64-65 and 68-73 are pending and currently under examination in this office action.
Priority
This instant application 18/270,900 filed 07/05/2023 is a 371 of PCT/US2022/012081filed on 01/12/2022, which claims benefit of US provisional application 63/138,556 filed on 01/18/2021.
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. The disclosure of the prior-filed application, Pro application No. 63/138,556 fails to provide adequate support in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
It’s noted US provisional application 63/138,556 only discloses the therapeutic agent is used for treatment of tissue inside of the body, including treatment of various body cavities (See page 5). Pro application ‘556 does NOT explicitly disclose “tissue beyond a superficial level”, or “the superficial layer is an exocervix” (instant claim 68), “superficial layer is epidermis around eyelids” (instant claim 69).
US provisional application 63/138,556 also does NOT disclose following subject matter:
composition having pH less than 2 and a viscosity greater than water as recited in claim 41;
2) the agent treats conditions caused by HPV as recited in instant claim 46;
3) the amount of thickening agent as recited in instant claims 44 and 64.
Information Disclosure Statement
The information disclosure statement filed 11/10/2023 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language.
Claim Objections
Claim 41 reciting “tissue beyond a superficial level” and “the tissue beyond the superficial layer” are confusing. It’s not clear if the “superficial level” and “superficial layer” refer to the same subject matter wherein tissue beyond superficial level might comprise multiple layers.
Claim 50 reciting “tissue beyond a superficial level” and “the tissue beyond the superficial level” . It’s not clear if the superficial level refers to superficial layer.
Claim 69 directed to epidermis around eyelids is preliminarily objected to because they do not read on uterine endometrium and related superficial layer.
Claim 72, typo error “release form the applicator” should read released from the applicator.
Specification
The disclosure is objected to because of the following informalities:
Instant specification (See PgPub US20250332127A1 [0028], [0037], etc. ) recite "superficial level" and "superficial layer" in the same sentence, which is confusing and it’s not clear if they are referring to the same subject matter.
Drawings
The drawings are objected to because there are multiple figures on the same page and the title of the graphs are missing from Figures 1-27. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Written Description Rejection
Claims 41-48, 50, 61, 64 and 68-73 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 method genus of treating variety of tissues beyond a superficial level with any therapeutic agent as claimed . This is a written description rejection, rather than an enablement rejection under 35 U.S.C. 112, first paragraph. Applicant is directed to the MPEP 2163 and Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1st "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
MPEP 2163.02 states “ Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention, and that the invention, in that context, is whatever is now claimed.”
Instant claims are drawn to method of treating tissues beyond a superficial level comprising applying to the tissue a composition containing a therapeutic agent, a thickening agent ...the therapeutic agent remaining on the tissue for a predetermined period of time to penetrate the tissue beyond the superficial layer. The tissue beyond a superficial level is broad term encompassing vast variety of tissues at different locations. The therapeutic agent and thickening agent are also broad term. Applicant is required to provide adequate written description and evidence of possession of the claimed method genus.
MPEP 2163 II states; “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above)”. While applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. “A representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus” MPEP 2163 II.
Instant specification disclosed an apparatus/system for delivering therapeutic agents, but only disclosed working example wherein TCA passed through the apparatus/system (See Table 1), NO composition comprising TCA in presence of any thickening agent is delivered to penetrate a tissue beyond a superficial level that achieved alleged penetration depth. Instant specification does not disclose any working example of composition comprising any other therapeutic agent in presence of any thickening agent penetrate a superficial level. Instant specification does not disclose any working example related to other superficial layer (e.g. epidermis around eyelids). In the absence of sufficient recitation of working example, the specification does not provide adequate support for the claimed method genus. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the method genus wherein therapeutic agent genus can penetrate the superficial layer for treatment of vast variety of tissues/conditions as claimed. The specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.
Applicant is reminded that MPEP 2161 II makes clear that “ The written description requirement is separate and distinct from the enablement requirement”.
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 41-48, 50, 61-62, 64-65 and 68-73 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 41 recites a method for treatment of tissue beyond a superficial level comprising applying to tissue a composition containing a therapeutic agent, the composition having a thickening agent to provide a viscosity greater than a viscosity of water, over 50% weight by weight of the agent and having a pH less than 2, the therapeutic agent remaining on the tissue for a predetermined period of time to penetrate the tissue beyond the superficial layer.
The term “treatment of tissue” is vague and indefinite. It’s not clear what treatment of the tissue is referred to and where the tissue is located. Is it method of restoring or ablating the issue? “The superficial layer” lacks antecedent basis as it is unclear whether tissue beyond a superficial layer refers to the same subject matter as tissue beyond a superficial level. It’s not clear if the “superficial level” and “superficial layer” refer to the same subject matter, wherein tissue beyond superficial level might comprise multiple layers.
The limitation “a thickening agent to provide a viscosity greater than a viscosity of water” is indefinite. The term “greater than” is a relative term and one of ordinary skill in the art would not be reasonably apprised of the extent/scope of the viscosity.
As for the limitation “over 50% weight by weight of the agent”. It’s not clear which agent is referring to, the therapeutic agent or the thickening agent?
The “ predetermined period of time to penetrate the tissue beyond the superficial layer” is vague and indefinite. It’s not clear how long is the predetermined period of time, minutes or hours?
As such, the lack of clarity render claim 41 indefinite, since the limitations do not clearly set forth the metes and bounds of the patent protection desired. Claims 42-48, 50, 61-62, 64-65 and 68-73 are rejected due to dependency on claim 41.
Claims 42-43, 45-46, 48 and 62 depend on claim 41 and recite “the agent” . Claim 41 recites “therapeutic agent “ and thickening agent”. It’s not clear which agent are these dependent claims refer to.
Claim 65 contains the trademark/trade name Carbopol. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a cross-linked polyacrylic acid polymer (also known as Carbomer) as a thickener, accordingly, the identification/description is indefinite.
Claim 70 recites limitation “wherein the viscosity exceeds a viscosity of CO2 and saline”. It’s not clear “a viscosity of CO2 and saline” is the viscosity of CO2, or viscosity of saline, or viscosity of combination of CO2 and saline. Please note the viscosity of CO2 and saline vary significantly at different temperature, phase and concentration, etc. and different combination of CO2 and saline would result different viscosity.
Claims 72 recites limitation wherein the composition conforms to a target surface. It’s not clear how the composition conforms to the target tissue beyond the superficial layer and how this limitation further limit the active step of applying the composition.
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 41-48, 50, 61-62, 64-65, 68-73 are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks et al. (US20130210776A1) in view of Shikhman et al. ( US20180133446A1, hereafter “Shikhman’ 446”, corresponding to US 10485962 B2, Applicant’s IDS dated 11/10/2023) and Kucukozkan et al. (International Journal of Gynecology & Obstetrics Volume 84, Issue 1, January 2004, pages 41-46 https://doi.org/10.1016/S0020-7292(03)00337-0, Chemical ablation of endometrium with trichloroacetic acid).
Hendriks teaches composition comprising active agent (e.g. trichloroacetic acid TCA) and at least one thickener, an applicator comprising aforementioned composition and method of treating variety of lesions with aforementioned composition, e.g. skin hyperpigmentation, acne, keratosis pilaris, actinic keratosis, mouth ulcers, eyelid xanthelasma, etc. (See abstract, Examples 1-8, claims 1-15).
Regarding the active agent, Hendriks teaches composition comprises trichloroacetic acid TCA in the range of 0.1-50% w/w and concentrations higher than 50% TCA w/w are also effective (See [0008][0017])(which also read on instant claim 62). Hendriks teaches TCA effective for treating disorder caused by HPV (See [0004])(which reads on instant claim 46). Please note the biological activity of TCA is the property of TCA. Hendriks teaches TCA effective for treating eyelid xanthelasma, which is considered as read on instant claim 69.
Regarding the thickening agent, Hendriks teaches variety of thickeners, e.g. polysaccharide thickener, crosslinked acrylic acid polymer and polysiloxanes, or mixtures thereof at various concentration (See [0018]-[0021], Examples 1-8).
Regarding the pH limitation, Hendriks teaches composition has a pH below 4, e.g. pH <2 ( See [0016], Examples 1-8). Hendriks explicitly teaches embodiments wherein pH<2 (See Example 4).
Regarding the viscosity limitation of claim 41 and 70, Hendriks teaches various viscosity, e.g. the composition has a viscosity of at least 3000 mPas as measured using rotary viscometry at 25 degree (See [0012]-[0015], Examples 2-7, claims 2-4)(which is considered as greater than viscosity of water and exceeds CO2 and saline ).
Regarding claims 42, 61 and 73, Hendriks teaches the thickener provides the composition with an increased viscosity, making it easier to focus the active ingredient on the intended location, preventing the spreading of the composition to locations where its action is not desired. Also, the thickener improves the time the active ingredient remains on a treated surface, improving the efficacy of the composition, etc. (See [0011], [0052]).
Regarding claims 45 and 72, Hendriks teaches composition may be applied by using a suitable applicator and applicator device comprising the composition (See [0014], [0024], [0044]-[0045], claim 13).
Regarding claim 65, Hendriks teaches the thickener comprises Carbopol® which shows an excellent stability in the presence of TCA, allowing for colorless compositions, or excellent color control in case the composition comprises a colorant. Carbopol polymers, also called carbomers, are polymers of acrylic acid cross-linked with polyalkenyl ethers or divinyl glycol (See [0019][0021], claim 10 ). Hendriks further teaches Carbopol allows for an excellent control of the viscosity of the formulation, in the range of 0.5-3% w/w (See [0022], claim 11)(which also reads on instant claims 44 and 64). Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05.
Hendriks collectively method of treating variety of conditions at different tissue/locations with composition comprising trichloroacetic acid (TCA) and thickener. Hendriks does not explicitly teach the tissue beyond a superficial level. However, the active agent trichloroacetic acid (TCA) might penetrate the superficial level/layer and treat the tissues beyond.
Hendriks is silent about treating specific tissue beyond a superficial level, e.g. uterine endometrium.
Shikhman’ 446 teaches a system/apparatus and method for delivering therapeutic agents to a patient, e.g. a uterine cavity for endometrial ablation(See [0002], [0015], [0044], claims 1-20). The method of endometrial ablation is considered as treatment of tissues beyond a superficial level/layer (uterine cavity), wherein the superficial layer is uterine endometrium (which also reads on instant claim 47, 50 and 68).
Shikhman’ 446 teaches the therapeutic agent is a chemical agent for endometrial ablation (See [0013]) and explicitly teaches trichloroacetic acid (TCA) or derivative delivered into uterine cavity for chemical endometrial ablation, wherein TCA causes chemical cauterization on contact with tissue, but does not spread beyond where it is directly applied (See [0044])(which reads on instant claims 42 and 62).
Regarding claims 43, 45 and 61, Shikhman’ 446 teaches the therapeutic agent is preferably injected at a controlled pressure to maximize the surface of exposure of the endometrium to the agent while preventing leakage to other areas (See [0012]-0013], claims 1, 3, 5, 9, 13 and 15-16). Shikhman’ 446 also teaches use of CO2 and/or saline in the pressure control system (See [0069], [0073])(which relates to claim 70).
The difference between Shikhman’ 446 and instant claimed invention is the composition comprising thickener agent which was already taught by Hendriks.
It would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of instant invention to incorporate the composition comprising TCA and thickening agent taught by Hendriks as the therapeutic agent in the method of chemical endometrial ablation taught by Shikhman’ 446, together with exploration/optimization based on general knowledge of tissue treatment (e.g. endometrial ablation, etc.), and arrive at the instantly claimed invention with reasonable expectation of success. Before the effective filing date of instant claimed invention, it was already known TCA could be delivered to uterine cavity for endometrial ablation through a pressurized system/apparatus as taught by Shikhman’ 446. Hendriks teaches composition comprising trichloroacetic acid (TCA) and thickener (e.g. Carbopol) in various amount and variety of viscosity. Trichloroacetic acid (TCA) is a well-established chemical cauterizing agent in dermatology and gynecology as taught by Hendriks and Shikhman’ 446. A person of ordinary skill in the art would be motivated to combine the teachings of Hendriks and Shikhman’ 446 because Hendriks teaches the composition comprising TCA and thickeners could provide desired viscosity for TCA to remain at target tissue.
Shikhman’ 446 and Hendriks are silent about the penetration depth into the tissue as recited in claims 48 and 71. The penetration depth is construed as the intended function/result of active step of applying the composition comprising the therapeutic agent which does not necessarily further limit the method claim. As stated in MPEP 2111.04: In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Further, the penetration efficacy is the property of the therapeutic agent (TCA). Kucukozkan teaches endometrial ablation by 95% TCA may readily be performed as an alternative treatment method in the management of dysfunctional uterine bleeding DUB(See abstract). A skilled artisan would have known to explore the concentration of TCA (and thickening agent ) and control the penetration depth through experimentation/ optimization based on the general knowledge of TCA and endometrial ablation to achieve optimum treatment outcome. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and general knowledge of TCA and tissue treatment/chemical ablation . Therefore, the invention as a whole is 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 41-47, 50, 61-62, 64-65, 68 and 72-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10485962 B2 in view of Hendriks et al. (US20130210776A1).
Reference claims are directed to an apparatus/system for delivering a therapeutic agent to a uterine cavity of a patient wherein therapeutic agent is a chemical ablative agent in contact with endometrium for endometrial ablation without leakage. Reference claims recite pressured injection system comprising storage unit that read on instant claims 43, 45 and 72.
Reference are silent about the composition comprising thickening agent. It’s common practice to formulate therapeutic agent into composition in the pharmaceutical industry.
The collective teachings of Hendriks is elaborated in preceding 103 rejection and applied as before. Hendriks collectively method of treating variety of conditions at different tissue/locations with composition comprising trichloroacetic acid (TCA) and thickener at variety of viscosity.
It would have been prima facie obvious to one of ordinary skilled in the art to incorporate the composition comprising TCA and thickening agent taught by Hendriks as the therapeutic agent in the pressured injection system for chemical endometrial ablation taught by reference. Reference claims provide a roadmap for a method of endometrial ablation by utilizing a pressured injection in delivering therapeutic agent into uterine cavity (beyond a superficial level). A skilled artisan would be motivated to combine the teaching of Hendriks and reference claims and reasonably expect TCA composition with desired viscosity could be delivered into uterine cavity (beyond a superficial level) for endometrial ablation and remain at the target area without leakage.
The instant application shares one common inventor/applicant with the reference patent. Based on the continuing data on the record, instant application is not related to the reference patent, thus no 35 USC 121 shield exists.
Claims 41-47, 50, 61-62, 64-65, 68 and 72-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11813423B2 in view of Hendriks et al. (US20130210776A1).
Reference claims are directed to an apparatus/system for delivering a pressurized ablation liquid to a uterine cavity of a patient wherein the liquid is a chemical ablative agent in contact with endometrium for endometrial ablation without leakage. Reference claims recite pressure controlled injection system that read on instant claims 43, 45 and 72.
Reference are silent about the liquid/composition comprising thickening agent.
The collective teachings of Hendriks is elaborated in preceding 103 rejection and applied as before. Hendriks collectively method of treating variety of conditions at different tissue/locations with composition comprising trichloroacetic acid (TCA) and thickener at variety of viscosity.
It would have been prima facie obvious to one of ordinary skilled in the art to incorporate the composition comprising TCA and thickening agent taught by Hendriks as the therapeutic agent in the pressured injection system for chemical endometrial ablation taught by reference. Reference claims provide a roadmap for a method of endometrial ablation by utilizing a pressured injection in delivering therapeutic agent into uterine cavity (beyond a superficial level). A skilled artisan would be motivated to combine the teaching of Hendriks and reference claims and reasonably expect TCA composition with desired viscosity could be delivered into uterine cavity (beyond a superficial level) for endometrial ablation and remain at the target area without leakage.
The instant application shares one common inventor/applicant with the reference patent. Based on the continuing data on the record, instant application is not related to the reference patent, thus no 35 USC 121 shield exists.
Conclusion
No claims are allowed.
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/L.M./ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628