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 Objections
Claims 45 and 50 are objected to because of the following informalities:
As to claim 49, “configured to release of an active pharmaceutical ingredient” should read “configured to release
As to claim 50, “a ingestible object” should read “an ingestible object” for grammar.
Appropriate correction is required.
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 locking assembly configured to maintain the device in the expanded configuration upon transfer of the device into the expanded configuration” in claim 1, “a biasing assembly” in claim 21, “a straining assembly configured to transfer the biasing assembly from the relaxed state into the strained state upon the device being removed from a packaging” in claim 22, “a trigger assembly configured to cause the device to transfer from the expanded configuration into the emptying configuration” in claim 44, “a trapping assembly configured for blocking a ingestible object while allowing chyme flow when the device is positioned at the ileocecal valve and in the expanded configuration” in claim 50.
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 2, 3, 12 and 54 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.
As to claim 2, the limitation of “its respective coupling head” in line 4 is unclear because no respective relationship was ever established between each free end of the locking member and the first and second coupling heads.
As to claim 3, the limitation of “wherein the respective coupling head of at least one free end of the locking member” is unclear because no respective relationship was ever established between each free end of the locking member and the first and second coupling heads.
Claim 12 recites the limitation "the basis of the extension" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 54 recites the limitation "the gastric environment" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kalfon (US 2020/0100888 A1).
As to claim 1, Kalfon discloses a device (140; see Figs. 1A-5B) for temporary residence at a predetermined location of the gastrointestinal tract of a subject (resides in stomach 511; however, see below), the device being configured to transfer from a closed configuration (“flexible state” – see at least para 0027) into an expanded configuration (“rigid state” – see at least para 0027), the device comprising:
at least two flexible arms (142, 144, 146), each of the two flexible arms having a first end (end attached to 153) and a second end (end attached to 155);
first and second coupling heads (153 & 155), wherein the first end of each of the two flexible arms is coupled to the first coupling head and the second end of each of the two flexible arms is coupled to the second coupling head (Figs. 1D, 1E);
a resiliently deformable member (111) configured to force the first and second coupling heads together to bend the at least two flexible arms thereby biasing the device in the expanded configuration (see para 0027-0030); and
a locking assembly (release pin 123 & corresponding opening in device closure pin 111) configured, to maintain the device in the expanded configuration, upon transfer of the device into the expanded configuration (para 0027, 0028),
the device being configured in the expanded configuration, when the device is positioned at the predetermined location of the gastrointestinal tract, to be retained at the predetermined location of the gastrointestinal tract (Fig. 5B, para 0041), and
the device being configured to transfer from the expanded configuration into an emptying configuration (configuration described in at least para 0004 & 0027 when device is removed), the device being configured to move past the predetermined location of the gastrointestinal tract in the emptying configuration (“a predetermined location” is broad in the sense that it could be referring to a particular part of the stomach, such as where the device is seen in Fig. 5A – the device, in the emptying configuration would be configured to move at least slightly deeper into the stomach in the emptying configuration due to its thinner profile).
Claim(s) 21 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticiapted by Ben Menacham et al. (WO 2018/102799, provided by applicant on 9/4/23 and hereafter referred to as “Menacham”).
As to claim 21, Menacham discloses a device (device seen in Figs. 16A-16C) for temporary residence at a predetermined location of the gastrointestinal tract of a subject (resides in the stomach – see para 0091), the device being configured to transfer from a closed configuration into an expanded configuration (para 0171), wherein:
when the device is in the expanded configuration, and positioned at the predetermined location of the gastrointestinal tract, the device is configured to be retained at the predetermined location of the gastrointestinal tract (para 0091, 0171),
when the device transfers from the expanded configuration into an emptying configuration, the device is configured to move past the predetermined location of the gastrointestinal tract (para 0030-0031, 0152, 0162, 0184),
the device further comprises a biasing assembly (2006a, 2006b) having a strained state (see Fig. 16B) and a relaxed state (see Figs. 16A), the biasing assembly being configured, when the device is in the closed configuration, to transfer from the relaxed state into the strained state (para 0170), and
the device being configured to transfer from the closed configuration into the expanded configuration when the biasing assembly is in the strained state (see Fig. 16B-16C).
As to claim 22, Menacham discloses the device of claim 21, wherein the device further comprises a straining assembly (priming member 2031) configured to transfer the biasing assembly from the relaxed state into the strained state upon the device being removed from a packaging (see para 0170 – the priming member could be activated after the device is removed from packaging in a manner as claimed).
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 of this title, 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.
Claim(s) 40, 44, 45 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kalfon in view of Menecham.
As to claim 40, Kalfon discloses the device of claim 1 as described above, but is silent to a container to temporarily at least partially enclose the device in the closed configuration, wherein the container is configured to degrade in environment conditions of the predetermined location of the gastrointestinal tract.
Menecham however discloses a container (“wrapper, capsule or band”) to temporarily at least partially enclose the device in the closed configuration, wherein the container is configured to degrade in environment conditions of the predetermined location of the gastrointestinal tract (para 0004, 0085, 0151, 0156).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Kalfon with a container to temporarily at least partially enclose the device in the closed configuration, wherein the container is configured to degrade in environment conditions of the predetermined location of the gastrointestinal tract. One would have been motivated to do so in order to provide the device in an arrangement that is easy for a patient to ingest as well as to keep the device in a compact state until it reaches the proper location (see para 0004, 0085, 0151, 0156 of Menecham).
As to claim 44, Kalfon discloses the device of claim 1 as described above, but does not expressly recite a trigger assembly configured to cause the device to transfer from the expanded configuration into the emptying configuration.
Menecham discloses a trigger assembly (“emergency release feature”) configured to cause the device to transfer from the expanded configuration into the emptying configuration (see para 0200).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kalfon to include a trigger assembly configured to cause the device to transfer from the expanded configuration into the emptying configuration, for the purpose of providing an emergency release feature (see para 0200 of Menecham).
As to claim 45, Kalfon discloses the device of claim 1 as described above, but is silent to wherein the device is configured to release of an active pharmaceutical ingredient at the predetermined location of the gastrointestinal tract in the expanded configuration.
Menecham however discloses release of an active pharmaceutical ingredient at the predetermined location of the gastrointestinal tract in the expanded configuration (see para 0003, 0071, 0074, 0079, 0081, 0082).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kalfon such that the device is configured to release of an active pharmaceutical ingredient at the predetermined location of the gastrointestinal tract in the expanded configuration. One would have been motivated to do so to treat a disease, disorder, or other clinically recognized condition, or for prophylactic purposes, and has a clinically significant effect on the body of the subject to treat and/or prevent the disease, disorder, or condition (see para 0082 of Menecham).
As to claim 47, Kalfon discloses the device of claim 1 as described above, and further wherein the predetermined location of the gastrointestinal tract is the stomach (511), the device being configured to be retained in the stomach in the expanded configuration (Fig. 5A, para 0040, 0041), but is silent to the device being configured to pass through the pyloric valve in the emptying configuration.
Menecham however discloses wherein the predetermined location of the gastrointestinal tract is the stomach, the device being configured to be retained in the stomach in the expanded configuration (see para 0077, 0091), and to pass through the pyloric valve in an emptying configuration (para 0099, 0133, 0152, 0200).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kalfon such that the device was configured to pass through the pyloric valve in the emptying configuration. One would have been motivated to do so in order to provide an alternative and/or emergency means for removal of the device from a patient (see para 0099, 0133, 0152, 0200 of Menecham).
Allowable Subject Matter
Claims 3, 6, 7, 11, 13, 16, 26, 48, 50, and 53 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 2, 3, 12, and 54 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.
The following is a statement of reasons for the indication of allowable subject matter:
While Kalfon discloses the device of claim 1 as described above, and Menecham discloses the device of claim 21 as described above, each of the noted claims includes limitations that are not taught or made obvious by Kalfon or Menecham in combination with the limitations of each corresponding independent claim.
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