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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a trigger assembly…” in claim claims 7 and 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
Claims 8-10 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 8 refers to “each activation signal when the device in the expanded configuration” in lines 3-4. However, claim 8 never previously introduced any activation signals, and thus this limitation lacks a proper antecedent basis.
Claim 9 recites “the activation signal” in line 3 and again in line 7. This limitation lacks a proper antecedent basis and/or is inconsistent with claim 8.
Claim 10 is rejected as it depends from a rejected claim.
Claim 21 recites “a dosage form for administering the dosage form comprising:” in line 21. This wording is unclear as it implies the dosage form administers itself.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 21 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 20 of copending Application No. 18023706 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 48 of copending Application No. 18548915 (reference application) in view of Ziaie et al. (US 2016/0114142 A1, hereinafter “Ziaie”). Although the instant claim 1 and claim 48 of the reference application are not identical, they are not patentably distinct from each other because they are drawn to the similar subject matter of a device for temporary residence at an ileocecal valve of a subject, the device comprising at least two flexible arms, first and second coupling heads, and a resiliently deformable member. The instant claim 1 is broader in the sense that it does not require a locking assembly, and is narrower in the sense that it positively requires a load of an active pharmaceutical ingredient, and requires that when in the expanded configuration, the device is configured to at least partially release the active pharmaceutical ingredient. However, it is known from Ziaie that drugs/pharmaceutical ingredients can be released at the ileocecal valve for treatment of large intestine diseases such as Crohn disease, inflammatory bowel disease, c. difficile infection, and colon cancer (see para 0033 of Ziaie) and therefore the instant claim 1 is obvious over claim 48 of the reference application.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claims 2-7, and 11-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 8-10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 20 is allowed.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 1, the only rejection is currently the nonstatutory double patenting rejection made above. If the double patenting rejection were to be overcome, the closest prior art appears to be Burnett (US 2007/0178160 A1) and Bates et al. (WO 02/0215962A2, hereinafter “Bates”), both cited by applicant on 2/27/25 IDS. Burnett discloses:
A device (see Figs. 7A-7C) for temporary residence at an ileocecal valve of a subject (para 0063), the device comprising:
at least two arms (arms of scaffold 54), each arm of the at least two arms comprising a first end and a second end (see points at which arms are attached); the arms configured to be biased into an expanded configuration (see Fig. 7C and paragraphs 0014, 0015, 0044-0047 describing how scaffold can be made with shape-memory material),
a load of an active pharmaceutical ingredient (drug within dispensing member 56),
wherein in the expanded configuration, and positioned at the ileocecal valve, the device is configured to be retained at the ileocecal valve of the subject while allowing chyme flow (para 0047, 0063),
and wherein, when in the expanded configuration and positioned at the ileocecal valve, the device is configured to at least partially release the active pharmaceutical ingredient (see para 0042, 0044-0047, 0063).
However, Burnett is silent to:
first and second coupling heads, wherein the first end of each arm is coupled to the first coupling head and the second end of each arm is coupled to the second coupling head;
a resiliently deformable member configured to force the first and second coupling heads together to bend the arms thereby biasing the device in the expanded configuration
and wherein the device is configured to transition from the expanded configuration into an emptying configuration, wherein in the emptying configuration the device is configured to pass through the ileocecal valve.
The examiner acknowledges the Written Opinion of the International Searching Authority for corresponding PCT/IB2021/057884 (submitted by applicant on 2/27/25), however disagrees with the assessment of claim 1. The Written Opinion states that Burnett discloses first and second coupling heads, with the citation “see the points at which the arms are attached in Fig. 7C for example”. However, Fig. 7C, as well as the rest of the disclosure of Burnett is vague at best in terms of how the arms are attached. In other words, it is not clear if the arms are directly connected to each other or if there are distinct coupling heads which connect the arms. The examiner also disagrees with the assessment that wherein in the emptying configuration the device is configured to pass through the ileocecal valve. Burnett discloses its devices being removed orally, nasally or transcutaneously by pulling them in a reverse manner, and never discusses any particular diameters or other factors that imply it is possible for the device to be configured to pass through the ileocecal valve as claimed.
Claims 2-18 depend from claim 1. Each claim discloses limitations that are not found within or obvious over claim 48 of copending Application No. 18548915.
As to claim 20, the claim recites limitations similar to claim 1 in addition to other limitations. The closest prior art appears to be Burnett, however Burnett is silent to at least the limitations of first and second coupling heads, wherein the first end of each arm is coupled to the first coupling head and the second end of each arm is coupled to the second coupling head; and a resiliently deformable member configured to force the first and second coupling heads together to bend the arms thereby biasing the device in an expanded configuration, external dimensions that enable the dosage form to be blocked by the device while allowing chyme flow when the device is positioned at the ileocecal valve of the subject in the expanded configuration and when the dosage form reaches the region of the ileocecal valve; wherein the amount of the emptying agent is sufficient to cause an environment of the ileocecal valve to reach at least one activation environmental condition thereby causing the device to transition into the emptying configuration when the device is positioned at the ileocecal valve of the subject in the expanded configuration and when the dosage form is blocked by the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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/James D Ponton/Primary Examiner, Art Unit 3783