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 and
Status of the Claims
2. Applicant’s election of Group I, claims 1-4 and 7, drawn to a compound (Z) according to either formula (1) or (2) and its composition thereof; a biological tissue embrittling agent comprising compound (Z); and a kit thereof, in the reply filed on December 8, 2025 is acknowledged with appreciation. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
3. Claims 5 and 6 (Group II), drawn to a method for detaching a biological tissue surface, are currently withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
4. Applicant further elected the species of compound (Z-1-1) as the main component and compound (Z-1-2) as the minor component in the compound (Z-1) (page 2 of Applicant’s Remarks). However, it is noted that the instant claims recite a compound (Z) represented by either the formula (1) or (2) (see lines 1-2 of Claim 1). Accordingly, compound (Z-1-1) is provisionally elected for examination:
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5. Applicants’ elected species of the compound of formula I was found to be free of the prior art. However, no claim reads solely on the elected species. In accord with MPEP 803.02 the search was extended to the extent necessary to determine patentability of the Markush-type claim. As discussed in the 102 rejection below, art was found that reads on the Markush-type claim. In accord with MPEP 803.02 the search is not extended unnecessarily to all species. The scope of the independent invention that encompasses the elected species is as follows:
A compound according to formula (1) of claim 1, wherein one of the “X” moieties is -C(O)-Y-(AO)n-R; wherein “-Y-” is O, N, or S; “A” is -CH2-CH2-, and “n” is 12.
The non-elected compound species are presently withdrawn from consideration as drawn to non-elected subject matter.
6. Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
7. Claims 1-4 and 7 are under examination with the elected species and are the subject of this Office Action.
Priority
8. Applicant has not filed an English language translation of foreign priority JP Application No. 2020-216704. It is suggested that a certified translation of every foreign benefit application or Patent Cooperation Treaty (PCT) application not filed in English be submitted. See 35 U.S.C. 119(b)(3) and 372(b)(3) and 37 CFR 1.55(g)(3)(i) and 41.154(b). A showing of priority that relies on a non-English language application is prima facie insufficient to overcome an intervening reference if no certified translation of the application is on file. See 37 CFR 41.154(b) and 41.202(e).
Information Disclosure Statement
9. The information disclosure statements (IDS) submitted on June 23, 2023 and January 23, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner, please refer to the signed copies of Applicant’s PTO-1449 forms, attached herewith.
Specification
10. Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
11. The abstract of the disclosure is objected to because the use of compound (Z) has not been provided. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112(b)
12. 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.
13. Claim 1 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.
14. In claim 1, line 17, the recitation of “… at least one of n As is an ethylene group;” is confusing because it is not clear what is intended by “n As.”
In view of a broadest reasonable interpretation, the limitation of “at least one of n As is an ethylene group” is construed to mean “at least one A is an ethylene group.”
15. Claims 2-4 and 7 are rejected as being dependent upon and including all of the limitations of claim 1.
Claim Rejections - 35 USC § 112(a)
16. 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.
17. Claims 1-4 and 7 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 claims contain 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.
18. The claims contain 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, at the time the application was filed, had possession of the claimed invention. In particular, support cannot be found for the full scope of compounds of formulas (I) and (2), as instantly claimed.
19. The MPEP §2163 states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. In the case of chemical entities, Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), which notes that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, “not a mere wish or plan for obtaining the claimed chemical invention.” While the court recognizes that, “[i]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass” (Id.), it is also recognized that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim and/or the genus must be sufficiently detailed to show that applicant was in possession of the claimed invention as a whole (see Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)). If a genus has substantial variance, the disclosure must present a sufficient number of representative species that encompass the genus in order to adequately describe the genus (i.e., the disclosure must describe a sufficient variety of species to reflect the variation within that genus). See MPEP § 2163. Otherwise, as stated by the court in Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company (Fed. Cir. 2010), “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus.
20. In the instant case, it is evident that the genus of compound “Z” embraced by formulas (1) or (2) of claim 1 has substantial variance. Indeed, the genus is virtually without limit, embracing hundreds of millions of potential compounds bearing little structural resemblance to one another. Yet, the instant Specification discloses only approximately five structurally related compound species, i.e., Compounds Z-1, Z-2, Z-3, Z-4, and Z-5 (see Examples 1-5 at pages 19-24).
21. While the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad generic. For example, in In re Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d 1008 (Fed. Cir. 1989). In the instant case, it is similarly determined that the disclosure of 14 structurally related compounds does not adequately describe a subgenus embracing hundreds of millions of additional compound species bearing no structural relationship with those 14 disclosed compounds. That is, the Specification does not disclose a sufficient variety of species to reflect the extreme variance in the genus.
22. The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
As such, claims 1-4 and 7 are rejected.
Claim Rejections - 35 USC § 102
23. 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.
(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.
24. Claims 1-4 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schellengberg et al., U.S. 6,020,373 A, (cited on Applicant’s IDS of June 23, 2023).
Claim 1 recites a compound (Z) according to either Markush group of formula (1) or (2) of claim 1:
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, wherein the scope of the independent invention that encompasses the elected species is as follows:
a compound according to formula (1) of claim 1, wherein one of the “X” groups is -C(O)-Y-(AO)n-R; wherein “-Y-” is O, N, or S; “A” is -CH2-CH2-, “R” is CH3; “n” is 4 to 12; and the other “X” groups are carboxylate moieties. Claim 2 is drawn to a composition comprising the compound (Z) according to claim 1.
Claim 3 is drawn to a biological tissue embrittling agent comprising the compound (Z) according to claim 1. Claim 4 is drawn to claim 3, wherein the biological tissue is gastrointestinal epithelium, mucosa, skin, or connective tissue.
Claim 7 is drawn to a biological tissue detachment kit comprising the biological tissue embrittling agent according to claim 3.
25. Schellengberg et al. teach the compound MPEDTA:
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, wherein “n” is 6-10, which is the same as compound species of Applicant’s instant formula (1) wherein three Xs are carboxylate groups; and one X is a group represented by formula (3): -C(O)-Y-(AO)n-R wherein -Y- is -NH-, A is ethylene, n is 5-11, and R is CH3 (see column 5).
26. Schellengberg et al. teach a pharmaceutical formulation comprising MPEDTA together with one or more pharmaceutically acceptable carriers (column 6, lines 1-11).
27. Regarding claims 3 and 4, drawn to a “biological tissue embrittling agent,” Applicant is additionally reminded that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). In the instant case, the compound structure taught by Schellengberg et al. is identical to those recited by the instant claims.
See also MPEP 2112.01: Composition, Product, and Apparatus Claims [R-10.2019]
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I. PRODUCT AND APPARATUS CLAIMS — WHEN THE STRUCTURE RECITED IN THE REFERENCE IS SUBSTANTIALLY IDENTICAL TO THAT OF THE CLAIMS, CLAIMED PROPERTIES OR FUNCTIONS ARE PRESUMED TO BE INHERENT
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Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).
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See also In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971) (Claim 1 was directed to a parachute canopy having concentric circumferential panels radially separated from each other by radially extending tie lines. The panels were separated "such that the critical velocity of each successively larger panel will be less than the critical velocity of the previous panel, whereby said parachute will sequentially open and thus gradually decelerate." The court found that the claim was anticipated by Menget. Menget taught a parachute having three circumferential panels separated by tie lines. The court upheld the rejection finding that applicant had failed to show that Menget did not possess the functional characteristics of the claims.); Northam Warren Corp. v. D. F. Newfield Co., 7 F. Supp. 773, 22 USPQ 313 (E.D.N.Y. 1934) (A patent to a pencil for cleaning fingernails was held invalid because a pencil of the same structure for writing was found in the prior art.).
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28. Regarding claim 7, drawn to a “biological tissue detachment kit,” the instructions for use included in a product/ kit or article manufacture constitute an “intended use” for that product/kit or article of manufacture. Intended use does not impart patentable weight to a product. See MPEP 2111.03: Intended use recitations and other types of functional language cannot be entirely disregarded. However, in apparatus, article and composition claims, intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963).
29. In the instant case, the claims are drawn to an old product, in the form of a kit. The intended use, which is for “biological tissue detachment,” lacks a functional relationship because the kit does not physically or chemically affect the chemical nature within the article of manufacture (product), and furthermore, the old product can still be used by the skilled artisan for other purposes. Therefore the old product is unpatentable over the prior art, because it functions equally effectively with or without the instructions, and accordingly no functional relationship exists between the instructions for use and the product.
See In re Haller 73 USPQ 403 (CCPA 1947), where it is held that application of printed matter to old article cannot render the article patentable. In the opinion text of In re Haller, it is stated that: Whether the statement of intended use appears merely in the claim or in label on the product is immaterial so far as the question of Patentability is concerned. . . In accordance with the patent statutes, an article or composition of matter, in order to patentable, must not only be useful and involve invention, but must also be new. If there is no novelty in an article or composition itself, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is intended. The difficulty is not that there can never be invention in discovering a new process involving the use of an old article, but that the statutes make no provision for patenting of an article or composition which is not, in and of itself, new.
Also see In re Venezia 189 USPQ 49 (CCPA 1976), where kits are drawn to the structural attributes of interrelated component parts and not to activities that may or may not occur. Further, In re Miller 164 USPQ 46 (CCPA 1969) and In re Gulak (CAFC) 217 USPQ 401 relate to a mathematical device and to a measuring cup respectively as well as In re Ngai, 70 USPQ2d 1862 (CAFC 2004). In each of these cases, the printed matter is considered a patentable distinction because the function of the device depends upon the printed matter itself, which is a patentable distinction because the function of the device depends upon the printed matter itself, which is a part of the substrate; without the printed indicia or numbers, the substrates lose their function. Such is not the case with the instantly claimed product. The claimed product remains fully functional absent the printed instructions for use.
As such, claims 1-4 and 7 are anticipated.
Conclusion
20. Claims 1-7 are pending. Claims 5 and 6 are presently withdrawn from consideration as directed to a non-elected invention. Claims 1-4 and 7 are rejected. No claim is currently allowable.
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANET L COPPINS/Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628