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 without traverse of Group II, corresponding to claims 56-58, 60, 61, 63, and 72-75, in the reply filed on September 16, 2025, is acknowledged. The examiner is withdrawing his requirement for an election of species at the present time in view of the breadth and relative heterogeneity of the claims of Group II. As such, all claims of Group II are examined.
Status of the Claims
Claims 2, 5, 11-13, 17, 19, 21-28, 30, 31, 34-40, 45-47, 50, 51, 56-58, 60, 61, 63, and 72-75 are pending. Claims 2, 5, 11-13, 17, 19, 21-28, 30, 31, 34-40, 45-47, 50, and 51 are preliminarily withdrawn. Claims 56-58, 60, 61, 63, and 72-75 are examined.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Further, Figures 3A-3F and 4B-4C are illegible. The examiner cannot determine which dots and/or lines/bars correspond to the key. Clearer graphs are requested. For example, in 4B “APT20E10” is indistinguishable from “KPE10 Inject.”
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.
Claim 63 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the claimed dependent limitations below are purely functional recitation with no additional limitation of structure for a further limiting claim. For example, this claim recites:
“The method of claim 56, wherein the mucoadhesive gel binds with the sub-mucosa or a tissue defect and shrinks or contracts, thereby approximating the margins of defect and providing a tamponade effect.”
The above examples are the dependent limitations, which are required to be further limiting, although there are no further limiting structural limitations or steps. A functional result is merely claimed.
These functional recitations therefore include any and all possible structures (composition ingredients and formulation techniques) to achieve the result/function. This type of claiming results in a single means claim, i.e., where a means recitation does not appear in combination with another recited element of means, is subject to an enablement rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714-715, 218 USPQ 195, 197 (Fed. Cir. 1983) (A single means claim which covered every conceivable means for achieving the stated purpose was held nonenabling for the scope of the claim because the specification disclosed at most only those means known to the inventor.). When claims depend on a recited property, a fact situation comparable to Hyatt is possible, where the claim covers every conceivable structure (means) for achieving the stated property (result) while the specification discloses at most only those known to the inventor.
Applicant is reminded that 35 U.S.C. § 112, sixth paragraph, when enacted, was a statutory response to the Supreme Court’s decision in Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946); and was a way to use to limit the scope to what the inventor described in the specification.
This general prohibition against the use of “purely functional claim language” (and the more specific Halliburton rule) has not been completely eliminated. Rather, “purely functional claim language” is now permissible but only under the conditions of 35 U.S.C. § 112, sixth paragraph, i.e., if its scope is limited to the corresponding structure, material, or act disclosed in the specification and equivalents thereof.
In the absence of such limited construction, the concerns expressed by the Court in Halliburton are still applicable to prohibit the use of “purely functional” claim language. Hence, any claim that includes purely functional claim language, and which is not subject to the limited construction under 35 U.S.C. § 112, sixth paragraph, fails to meet the requirements of 35 U.S.C. § 112, first paragraph, according to reasoning in Halliburton and thus is unpatentable.
While the particular claim language involved in the Supreme Court's Halliburton decision uses the word “means,” the issue was claiming in a purely functional manner, a practice condemned by pre-existing case law, and not any particular problem associated uniquely with the word “means” as distinguished from other purely functional words and phrases. With regard to pre-existing case law around the time of the Supreme Court's Halliburton decision, see In re Fuetterer, 319 F.2d 259, 263 (CCPA 1963), wherein the Court of Customs and Patent Appeals explained:
In the Fullam case [In re Fullam, 161 F.2d 247 (CCPA 1947)], this court stated that some claims were properly rejected as “functional in claiming merely the desired result well known to and sought after by workers skilled in the art.” Claims directed merely to a “desired result” have long been considered objectionable primarily because they cover any means which anyone may ever discover of producing the result. See, e.g., O'Reilly v. Morse, 15 How. 62; Heidbrink v. McKesson, 290 F. 665.
When an applicant has not given notice to the public that his or her purely functional claim element is to be limited by the application of 35 U.S.C. § 112, sixth paragraph, a first USPTO concern is that the claim is indefinite under 35 U.S.C. § 112, second paragraph. A second USPTO concern is that such unlimited purely functional claiming may reasonably be construed to encompass any and all structures for performing the recited function, including those which are not what the applicant invented. Thus, it is doubly critical that the USPTO be in possession of such public notice when making a determination to grant a patent. That is, when the limitation encompasses any and all structures or acts for performing a recited function, including those which were not what the applicant had invented, the disclosure fails to provide a scope of enablement commensurate with the scope of the claim and the claim would violate the prohibition of Halliburton.
The Supreme Court’s Halliburton case remains viable for claims having purely functional claim language which is unlimited either by (1) the application of 35 U.S.C. § 112, sixth paragraph, or (2) the additional recitation of structure.
In the present case, these claim limitations violate the rule set forth in Halliburton, because the claims are not limited by the application of 35 U.S.C. § 112, sixth paragraph, and they do not contain any additional recitation of structure. As such, these claims are unpatentable under 35 U.S.C. § 112, first paragraph, for lack of an enabling disclosure commensurate with the scope of the claims.
Without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). See also Datamize LLC v. Plumtree Software Inc., 75 USPQ2d 1801 (Fed. Cir. 2005) where a claim directed to a software based system for creating a customized computer interface screen recited that the screen be "aesthetically pleasing," which is an intended result and does not provide a clear cut indication of scope because it imposed no structural limits on the screen. Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197 (Fed. Cir. 1983); Ariad, 598 F.3d at 1340, 94 USPQ2d at 1167. For instance, a single means claim covering every conceivable means for achieving the stated result was held to be invalid under 35 U.S.C. 112, first paragraph because the court recognized that the specification, which disclosed only those means known to the inventor, was not commensurate in scope with the claim. Hyatt, 708 F.2d at 714-715, 218 USPQ at 197. For more information regarding the written description requirement and enablement requirement under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, see MPEP §§ 2161-2164.08(c). Examiners should keep in mind that whether or not the functional limitation complies with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is a different issue from whether the limitation is properly supported under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, or is distinguished over the prior art.
Claim Rejections - 35 USC § 112
Claims 56-58, 60, 61, and 63 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 treatment of GI bleeding does not reasonably provide enablement for the prevention of GI bleeding. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to prevent GI bleeding commensurate in scope with these claims.
As stated in the MPEP 2164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue."
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
1. The nature of the invention
2. The state of the prior art
3. The predictability or lack thereof in the art
4. The amount of direction or guidance present
5. The presence or absence of working examples
6. The breadth of the claims
7. The quantity of experimentation needed, and
8. The level of skill in the art
The Nature of the Invention
Instant claims 56-58, 60, 61, and 63 are drawn to treating and preventing a gastrointestinal bleed.
Prevention means to anticipate or counter in advance, to keep from happening, etc. and there is no disclosure as to how one skilled in the art can reasonably establish the basis and the type of subject to which the instant compounds and compositions can be administered in order to have the "preventive" effect for a patient suffering or susceptible to a GI bleed.
The State of the Prior Art and the Predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening invitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat which specific diseases/conditions by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
According to an article by Dr. Anna E. Krigel, “Gastrointestinal Bleeding,”
https://www.nyp.org/digestive/gastrointestinal-gi-bleeding -date accessed October 10 2025.
“While it is not possible to prevent a GI bleed, you can reduce your chances of one by:
Limiting alcohol consumption
Limiting the use of NSAIDs
Managing any existing GI conditions, like diverticulosis, by consuming a high-fiber diet
Treating causes of ulcers, like Helicobacter pylori infections.”
As such, this article explains that it is not possible to prevent GI bleed.
The instantly claimed invention is highly unpredictable as discussed below: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instantly claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to the preventative effects of a gastrointestinal bleed from any source.
With regards to pharmaceutical compositions for and methods of preventing a GI bleed, there are various conditions that can ultimately cause a GI bleed, including trauma, cancer, and inflammation. Further, because of the broad range of individuals who can be affected by a GI bleed e.g., prevention of the disease is focused on a person’s risk of the same, which is not entirely predictable. It is known in the art that in order to establish a proper and effective prevention plan for any neurological condition using medication, it is necessary for a practitioner in the art area to establish definitively that a person is at risk for the same. No medications are disclosed in the art as being useful for the general prevention of such conditions without accounting for the particular cause of the disease and the specific patient population.
The Amount of Direction / Guidance Present and the Presence or Absence of Working Examples
Furthermore, there are no working examples in the instant Specification to support the prevention of GI bleed. There are no examples in which a condition is identified and prevented by applying a claimed composition to a subject prior to a bleeding episode. In fact, in some embodiments, a mucoadhesive agent adheres to a physiologic fluid as part of the mechanism of adherence to an impacted area on a subject. This fluid can be blood.
The level of the skill in the art
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art as described above, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine whether the compound exhibits the desired pharmacological activity. The amount of guidance or direction needed to enable the invention is inversely related to the degree of predictability in the art. In re Fisher, 839, 166 USPQ 24. Thus, although a single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements, in cases involving unpredictable factors, such as most chemical reactions and physiological activity, more teaching or guidance is required. In re Fishcher, 427 F.2d 839, 166 USPQ 24; Ex Parte Hitzeman, 9 USPQ 2d 1823.
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to definitively determine the specific population of individuals who would require prevention. To prevent GI conditions in any patient population, as the instant claims are drawn to, would require undue experimentation to both develop an animal model which would reasonably correlate with all forms of GI bleed and also to identify the portion of the population in which the instantly claimed compounds would need to necessarily be administered.
Thus, factors such as "sufficient working examples", "the level of skill in the art" and "predictability", etc. have been demonstrated to be sufficiently lacking in the instantly claimed methods. In view of the breadth of the claim, the chemical nature of the invention, and the lack of working examples regarding the activity of the claimed compounds, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention commensurate in scope with the claims.
The court in Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001, states that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which diseases can be treated or prevented by the compound encompassed in the instant claims, with no assurance of success.
Claim Rejections - 35 USC § 102
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.
Claims 56-58, 60, 61, 72, and 74 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Rubin et al., (US2014/0322341).
Rubin teaches hemostatic patches comprising a mucoadhesive and preferably comprising chitosan. See Abstract. The patch refers to a gel or other type of scaffold that comprises a mucoadhesive and a vasoconstrictant. See par. 20. Hydrogels other than chitosan can also be selected. The vasoconstrictant can be epinephrine. See par. 24. The vasoconstrictant can be encapsulated or immobilized by a bioabsorbable polymer, which can be chitosan See par.’s 25 and 37. An epoxide moiety can also be used. See par. 49. The chitosan can be effective in aiding in clotting of the wound and can be present in a gel form which could facilitate linkage with another compound. See par. 71. The gel can be used to stop bleeding and internal organ damage. See par. 79. The wound or injury to be treated can be discovered endoscopically in a colon, lung, GI system, GI tract, liver, lung, colon, or other internal area. See par.’s 82 and 101. Further, the gel can be applied/delivered through endoscopic, laparoscopic, arthroscopic, endoluminal, or transluminal placement. See par. 94. Conditions to be treated include ulcers, neoplasms, colitis, and for fistula occlusion, among others. It can be applied to a bleeding site via colonoscopy. See par. 95. Administration can be through injection, endoscopy, and can be in a form of a sustained release formulation that releases over days and even weeks. See par. 114. In some embodiments, the epinephrine or vasoconstrictor can be applied via a spray coating on the nanoparticles of the gel/hemostatic patch. See par. 70. This is considered a mucoadhesive coating. Further, any of the compositions can comprise a second pharmacologically active ingredient. See par. 38. In view of this, a POSA would immediately envisage including any anticancer agent or anti-inflammatory agent to treat GI inflammation or cancer, e.g.
As such, claims 56-58, 60, 61, 72, 74, and 75 are anticipated by the prior art.
Claim Rejections - 35 USC § 103
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.
Claims 56-58, 60, 61, and 72-75 are rejected under 35 U.S.C. 103 as being unpatentable over Rubin et al., (US2014/0322341), and in view of Surti et al., (US2017/0232141).
Rubin teaches hemostatic patches comprising a mucoadhesive and preferably comprising chitosan. See Abstract. The patch refers to a gel or other type of scaffold that comprises a mucoadhesive and a vasoconstrictant. See par. 20. Hydrogels other than chitosan can also be selected. The vasoconstrictant can be epinephrine. See par. 24. The vasoconstrictant can be encapsulated or immobilized by a bioabsorbable polymer, which can be chitosan See par.’s 25 and 37. An epoxide moiety can also be used. See par. 49. The chitosan can be effective in aiding in clotting of the wound and can be present in a gel form which could facilitate linkage with another compound. See par. 71. The gel can be used to stop bleeding and internal organ damage. See par. 79. The wound or injury to be treated can be discovered endoscopically in a colon, lung, GI system, GI tract, liver, lung, colon, or other internal area. See par.’s 82 and 101. Further, the gel can be applied/delivered through endoscopic, laparoscopic, arthroscopic, endoluminal, or transluminal placement. See par. 94. Conditions to be treated include ulcers, neoplasms, colitis, and for fistula occlusion, among others. It can be applied to a bleeding site via colonoscopy. See par. 95. Administration can be through injection, endoscopy, and can be in a form of a sustained release formulation that releases over days and even weeks. See par. 114. In some embodiments, the epinephrine or vasoconstrictor can be applied via a spray coating on the nanoparticles of the gel/hemostatic patch. See par. 70. A mucoadhesive coating is applied to the hemostatic component that is applied to a lesion. See par. 30. Further, any of the compositions can comprise a second pharmacologically active ingredient. See par. 38. In view of this, a POSA would immediately envisage including any anticancer agent or anti-inflammatory agent to treat GI inflammation or cancer, e.g.
Similarly, Surti teaches a method for treating a lesion site in a gastrointestinal tract. See Abstract. Surti also teaches treating tumors and sealing perforations, e.g. See par. 3. These include GI motility, GI infection, GI inflammation, lesions, wounds, endoscopic procedures, polypectomy, and others. See par. 4. Localized delivery to a target site can be through a catheter or injection with a therapeutic agent. See par. 6. The composition can be in the form of a hemostatic gel comprising a coating comprising an adhesion agent, including chitosan and sodium alginates. See par. 11. The adhesive agent can be a mucoadhesive agent. See par. 12. Ulcers and cancer are taught to be treated. See par. 19. The hemostatic composition and a protective coating can be delivered separately. The hemostatic layer can include hemostatic agents, such as epinephrine among a limited list of hemostatic agents. See par.’s 11 and 33. The composition can bind to a mucosal and submucosal layer at a site of a lesion. See par. 35 and 37. As mucoadhesive agents are often hydrophilic they are capable of forming bonds at the site. Additional therapeutic agents can be incorporated into the composition. See par. 84. These agent include antibiotics, among others. See par. 83. The composition can be applied through endoscopic techniques. See par. 91. The composition can be applied on the lesion itself to ensure the most complete coverage as possible. See par. 28. The mucoadhesive agent can adhere to the hemostatic agent or the mucous membrane by a physical or chemical force. See par. 37.
With regard to claim 63, the examiner notes that the gel is taught to interact with hydrophilic components to conform to a site of blood, e.g. The contracting or shrinking of the composition is a product of the components described therein.
It would have been prima facie obvious to a person of ordinary skill in the art prior art prior to the filing of the instant application to combine the teachings of Rubin and Surti to arrive at the claimed methods. One would be motivated to do so because the claimed agent epinephrine is known to be combined with biodegradable and mucoadhesive polymers for administration to treat lesions and stop bleeding. Further, such compositions can be in the form of an injectable gel that can be delivered by multiple means including through an endoscopic administration to the GI tract and other organs in combination with additional therapeutic agents. The mucoadhesive agent, including chitosan, can be coated and/or sprayed onto a lesion site. The composition can include a layer that is mucoadhesive and this would be understood to include a coating, e.g., to adhere to the location of a lesion or other area in which a composition is intended to target. Thus, a biodegradable gel comprising a hemostatic agent including epinephrine and including a mucoadhesive agent that can be a coating. As such, there is a reasonable and predictable expectation of success in arriving at the claimed methods in view of the cited prior art for the reasons set forth above.
As such, no claim is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D. BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 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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/JARED BARSKY/Primary Examiner, Art Unit 1628