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 of Species A (i.e., a single and specific dosing regimen as once every day for administration frequency, from about 30 IU/kg to about 300 IU/kg for dosage range, and at least 48 hours for timeframe of breakthrough bleeding prevention); and Species B (i.e., composition comprised within a capsule that is structured to deliver the FVIII into a peritoneal cavity as a single and specific swallowable device) in the reply filed on April 27, 2026, is acknowledged. 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)).
Please note claims 6-7 are rejoined for examination in light of the Examiner’s search.
Status of Claims
Claims 1-24 were originally filed on August 18, 2023.
The amendment received on October 27, 2023, canceled claims 22-24; and amended claims 1, 5-6, 8-18, and 20-21. The amendment received on April 27, 2026, amended claims 3, 5-6, 8-14, 16-18, and 21.
Claims 1-21 are currently pending and claims 1-7, 9-10, 13, 15, and 18-21 are under consideration as claims 8, 11-12, 14, and 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 27, 2026.
Priority
The present application is a continuation of PCT/US2022/017454 filed February 23, 2022, and claims priority under 119(e) to U.S. Provisional Application No. 63/1513,017 filed on February 24, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 27, 2023, is being considered by the examiner.
Claim Interpretation
For purposes of applying prior art, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation set forth below, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
For claim 9, with respect to a “long-circulating form” of FVIII, it is noted that the instant specification defines this term as referring to a form that has been modified with a delay agent that prolongs the in vivo half-life of the FVIII (See instant, [0064]). A “long-circulating form of FVIII” can include FVIII conjugated to any of PEG, PLA, PGA, PEO, PLLA, PDLA or another polymer, hydrogel or other delay agent (See instant, [0064]). Thus, the scope of claim 9 encompasses where FVIII is modified in such a manner as it extends it’s in vivo half-life relative to unmodified FVIII.
Claim Rejections - 35 USC § 112
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.
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.
CLAIM INTERPRETATION
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.
Claims 1-7, 9-10, 13, 15, and 18-21 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 limitations in claims 1-3, “the device is structured to deliver the FVIII into a peritoneal cavity of the subject,” and “the device is structured to deliver one or more payloads or doses into the peritoneal cavity of the subject at different times” in claim 19 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. It is noted that instant claims 1-3 do not expressly recite sufficient structure, material or acts for achieving the specified function (i.e., delivery the FVIII into a peritoneal cavity of the subject) as necessary as in prong three of the three-prong test below. Although the instant specification teaches examples of devices such as a dry composition filled inside a hollow, biodegradable microneedle constituting a solid tissue penetrating member (See instant, [0083]); and a sealed polyethylene balloon, a delivery construct (labeled Microsyringe), and an actuator in the form of two reactants and a valve with and without an expandable component (See instant, [0093], [0106]-[0127]), the instant specification fails to specifically define a correlation between the structure of the device and the function claimed (i.e., delivery the FVIII into a peritoneal cavity of the subject). Thus, there is no clear linkage between he structure, material, or acts and the function to satisfy prong three of the three prong test. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Please note that the Examiner is interpreting the scope of claims 1-3 such that the device is of the structure of a capsule without any additional structure (as elected by Applicants) in order to advance prosecution.
Claim Rejections - 35 USC § 112
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 1-7, 9-10, 13, 15, and 18-21 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. Claims 1-3 are directed to orally administering to a subject a swallowable device containing a payload comprising a composition comprising FVIII where he device is structured to deliver the FVIII into a peritoneal cavity of the subject…. However, it is unclear what constitutes delivery into a peritoneal cavity of the subject. The instant specification does not define what constitutes delivery into a peritoneal cavity of the subject. The peritoneal cavity is defined as a potential space between the parietal and visceral peritoneum (See O’Neill, K., “The Peritoneal (Abdominal) Cavity” available online at https://teachmeanatomy.info/abdomen/areas/peritoneal-cavity/, 10 pages (last updated May 2026) at pg. 1, 1st paragraph). It normally contains only a thin film of peritoneal fluid, which consists of water, electrolytes, leukocytes and antibodies, and acts as a lubricant (See O’Neill, pg. 1, 2nd paragraph). It can be divided into the greater and lesser peritoneal sacs where the greater sac contains the stomach, liver, spleen, and intestines (See O’Neill, pg. 2, 1st paragraph to pg. 3, 1st paragraph) (See also: Natl. Cancer Institute, “peritoneal cavity,” available online at https://www.cancer.gov/publications/dictionaries/cancer-terms/def/peritoneal-cavity, 2 pages (accessed on July 24, 2026)): teaching that the peritoneal cavity is the space that contains most of the organs in the abdomen including the liver, stomach and intestines). Since the peritoneal cavity contains many abdominal organs and also is a space surrounding the organs containing fluid, it is unclear whether the delivery of the FVIII is into the space containing the peritoneal fluid or if delivery into the stomach, which is an organ within the peritoneal cavity, constitutes delivery into a peritoneal cavity. Therefore, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the instant invention with respect to what constitutes delivery into a peritoneal cavity of a subject.
Please note that the Examiner is interpreting that the claim limitation with respect to delivery into a peritoneal cavity is met by delivery of the FVIII into an organ within the peritoneal cavity such as the stomach or small intestine in order to advance prosecution. Also please note that claims 4-5, 9-10, 13, 15, and 18-21 are rejected by virtue of their dependency.
Claims 2 and 13 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. Claims 2 and 13 recited that the device contains a dose of FVIII of from about 30 IU/kg to about 300 IU/kg. However, it is unclear what the kg is based on, e.g., the weight of the patient, or total weight of the device, especially, since the device contains this dose as opposed to the dose being administered to the subject. Therefore, an ordinary skilled artisan would be unable to ascertain the metes and bounds with respect to what the kg corresponds to.
Please note that the Examiner is interpreting that the device releases the composition comprising FVIII such that the composition is administered to the subject at a dosage of about 30 IU/kg to about 300 IU/kg per the weight of the patient in order to advance prosecution.
Claim Rejections - 35 USC § 102/103
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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 3-4, 9, and 21 are rejected under pre-AIA 35 U.S.C. 102 (a) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Imran et al. US 2019/0133937 A1 published on May 9, 2019.
For claims 3-4, 9, and 21, ‘937 claims a method for treating a clotting disorder such as Hemophilia A in a patient by providing a clotting factor (CF) such as FVIII that has been modified to increase a circulatory half-life of the FVIII molecule in a solid dosage form, the solid dosage CF shaped as a tissue penetrating member; penetrating the solid dosage CF through the intestinal wall and into the peritoneal cavity after oral ingestion by the application of force on the tissue penetrating member such that the tissue penetrating member is delivered into the peritoneal cavity and releasing a therapeutically effective dose of CF into the blood stream from the solid dosage CF in the peritoneal cavity to treat the clotting disorder (See ‘937 claims 75, and 87-92). The solid dosage CF is ingested by the patient (See ‘937, claim 79), and the solid dosage CF is provided in a swallowable capsule (See ‘937, claim 80). Thus, the ‘937 claimed invention anticipates the instant claimed method of treating hemophilia A by administering to a subject in need thereof a swallowable device (i.e., capsule containing a solid dosage form shaped as a tissue penetrating member) containing a payload (i.e., therapeutically effective dose of CF) formed from, or containing, a composition comprising FVIII (i.e., FVIII that has been modified to increase a circulatory half-life of the FVIII molecule), where the capsule is structured to deliver the FVIII into the peritoneal cavity of the subject (i.e., penetrating the solid dosage CF through the intestinal wall and into the peritoneal cavity after oral ingestion by the application of force on the tissue penetrating member such that the tissue penetrating member is delivered into the peritoneal cavity) as recited in instant claims 3, 9, and 21.
With respect to where the method is effective to protect the subject from breakthrough bleeding that is spontaneous bleeding for at least 48 hours and up to 120 hours, ‘937 does not expressly claim or determine whether the ‘937 ingested swallowable device comprising a composition of FVIII protects the subject from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours.
MPEP 2112-2112.02 states that when a reference discloses all the limitations of a claim except for a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention but has basis for shifting the burden of proof to applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). In the instant case, ‘937 expressly claims the instant treatment method of treating hemophilia A and expressly claims the instant manipulative step of orally (i.e., ingesting) administering a swallowable device comprising a solid dosage form of a composition comprising FVIII where the device is structured to deliver the FVIII into a peritoneal cavity of the subject. Thus, ‘937 claims the instant method, the instant manipulative step, and the instant administered swallowable device. The method being effective to protect the subject from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours would be dependent upon the manner of administration and the structure of the swallowable device.
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants’ swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject differs, and if so to what extent, from the swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject disclosed in ‘937. The cited art taken as a whole demonstrates a reasonable probability that the swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject of ‘937 is either identical or sufficiently similar to the claimed swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject that whatever differences exist are not patentably significant. Therefore, with the showing of the reference, the burden of establishing novelty or non-obviousness by objective evidence is shifted to the Applicants.
Merely because a function of a swallowable device and a manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject is not expressly disclosed in a reference does not make the known method patentable. The instant swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject possess inherent functions which might not be displayed in the tests used in ‘937. Accordingly, the disclosure of ‘937 is a sufficient basis that the swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject inherently would be effective to protect the subject from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours.
In the alternative, even if the claimed swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject are not identical to the ‘937 swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject with regard to some unidentified functions, the differences between that which is disclosed and that which is claimed are considered to be so slight that the ‘937 swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject is likely to inherently possess the same functions of the claimed swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject particularly in view of the similar characteristics which they have been shown to share (i.e., same swallowable device structure and same manipulative step). Thus, the claimed method resulting in the protection of the subject from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours would have been obvious to those of ordinary skill in the art under the meaning of USC 103. Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Accordingly, the disclosure of ‘937 anticipates or, in the alternative, renders obvious the instant claims 3-4, 9, and 21.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
103 - KSR Examples of 'Rationales' Supporting a Conclusion of Obviousness(Consistent with the "Functional Approach" of Graham)
Further regarding 35 USC 103(a) rejections, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) (KSR) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Also, a reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
Claims 1-2, 5-7, 10, 13, 15, are rejected under 35 U.S.C. 103 as being unpatentable over Imran et al. US 2019/0133937 A1 published on May 9, 2019.
For claims 1-2, 5, and 13, please see discussion of ‘937 for claim 3 supra. ‘937 satisfies the claim limitations of a method of treating hemophilia A by orally administering to a subject in need thereof, a swallowable device containing a payload formed from, or containing, a composition comprising FVIII, where the device is structured to deliver the FVIII into a peritoneal cavity of the subject.
For claims 1 and 5, with respect to the frequency of administration, ‘937 teaches that by providing for delivery of the CF into the wall of the intestine and/or peritoneal wall and adjoining tissue, e.g., peritoneal cavity for treating of a condition such as hemophilia A, provides a number of benefits over injected forms of CFs, e.g., FVIII, including a higher therapeutic ratio and reduced incidence and severity of adverse reactions (See ‘937, [0108]). These benefits are due to one or more of: (i) the much smaller doses that are delivered, (ii) doses are delivered daily vs weekly or monthly, and (iii) the fact that doses are delivered orally vs intravascularly (See ‘937, [0108]). For CFs such as FVIII that are typically delivered every two to three days weekly doses when injected, the therapeutic ratio can be increased by a factor in the range of three to seven when delivered in daily oral doses using the swallowable device (See ‘937, [0109]). ‘937 further teaches an embodiment where a prospective prophylactic dosing regimen for oral delivery of FVIII using a swallowable device would correspond to one pill per day orally and the amount of IU’s per pill would be calculated based on the recommendations of the active pharmaceutical ingredient’s manufacturer (See ‘937, [0138]).
For claims 2, and 13, with respect to the dosage of FVIII, as discussed supra for claim 3, ‘937 claims that a therapeutically effective dose of CF is delivered into the blood stream from the solid dosage CF in the peritoneal cavity to treat the clotting disorder where the CF is FVIII and the clotting disorder is hemophilia A. ‘937 also teaches in Table 1, dosages in IU per kg patient weight for treatment of hemophilia A and B with Factors VIII and IX respectively in various clinical settings where the dosage of FVIII ranges from 20 to 100 IU/kg patient weight depending on the clinical hemophilia A setting (See ‘937, [0104]; Table 1). As such, the FVIII dosage taught by ‘937 overlaps with the instantly claimed dosage range of about 30 IU/kg to about 300 IU/kg.
MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%". The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) Moreover, the Federal Circuit found that a prima facie case existed where a claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms and the prior art taught that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." In re Geisler, 116 F.3d 1465, 1469-82, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Therefore, the claimed dosage range of FVIII would have been obvious to one of ordinary skill in the art since the claimed range (i.e., about 300 to about 300 IU/kg) overlaps with the prior art dosage range of FVIII (i.e., 20 to 100 IU/kg).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to follow the teachings of ‘937 and orally administer a capsule as a swallowable device containing a payload formed from, or containing, a composition comprising FVIII in a dosage ranging from 20 IU/kg to 100 IU/kg body weight at a frequency of once every day to a subject in order to treat hemophilia A. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because a swallowable device such as a capsule containing FVIII was known to be formulated such that it is orally administered once daily in a dosage range of 20 to 100 IU/kg body weight of the patient to a subject in order to treat hemophilia A where such formulation was known to provide benefits over previous injectable formulations of a higher therapeutic ratio and reduced incidence and severity of adverse reactions and was known to deliver the FVIII into the peritoneal cavity of the subject as taught by ‘937. One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that a capsule as a swallowable device of ‘937 contains a payload formed from, or containing, a composition comprising FVIII as a CF to be administered orally and delivered into a peritoneal cavity to a subject in order to treat hemophilia A. Therefore, orally administering a capsule as a swallowable device containing a payload formed from, or containing, a composition comprising FVIII in a dosage ranging from 20 IU/kg to 100 IU/kg body weight at a frequency of once every day to a subject would support the treatment of hemophilia A by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
For claims 6-7, with respect to where the device contains a dose of FVIII of from about 1,000 IU to about 12,000 IU as recited in instant claim 6; and with respect to where the device contains a dose of FVIII of 3,000 IU, 6,000 IU, or 9,000 IU as recited in instant claim 7:
‘937 claims where a dose of FVIII in the solid dosage CF is in a range of about 400 to 10,000 IU (See ‘937, claim 93), which overlaps with the instantly claimed dose range of about 1,000 to about 12,000 IU. Moreover, ‘937 teaches that the therapeutically effective amount of a clotting factor such as FVIII ranges from about 1000 to 10,000 IU with specific dosage amounts of 1400, 1500, 2000, 2500, 3000, 3500, 4000, 4500, 5000, 6000, 7000, 7500, 8000, 9000, 9100 and 9500 IUs (See ‘937, [0104]). As such, the teachings of ‘937 satisfy the claim limitation with respect to where the device contains a dose of FVIII of 3,000 IU, 6,000 IU, or 9,000 IU as recited in instant claim 7.
MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%". The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) Moreover, the Federal Circuit found that a prima facie case existed where a claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms and the prior art taught that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." In re Geisler, 116 F.3d 1465, 1469-82, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Therefore, the claimed dose range of FVIII would have been obvious to one of ordinary skill in the art since the claimed range (i.e., about 1000 to about 12000 IU) overlaps with the prior art dose range of FVIII (i.e., about 400 to 10,000 IU). Thus, the teachings of ‘937 suggest the claim limitation with respect to where the device contains a dose of FVIII of from about 1,000 IU to about 12,000 IU as recited in instant claim 6.
For claim 10, with respect to where the FVIII is a recombinant human PEGylated FVIII:
‘937 teaches that a number of different types of available FVIII replacement therapies can be used including plasma derived FVIII, e.g., ALPHANATE and HUMATEP, recombinant human FVIII produced in mammalian cell lines from recombinant DNA technology, e.g., HELIXATE and ADVATE, a recombinant human FVIII that has been modified from the wild-type version, the most common modification being B-domain deletions, e.g., REFACTO and NOVOEIGHT, and recombinant human FVIII, wild-type or analog, modified via Fc fusion or PEGylation to increase its half-life in circulation, e.g., ADYNOVATE and ELOCTATE (See ‘937, [0121], [0126]). Therefore, the teachings of ‘937 satisfy the claim limitations with respect to where the FVIII is a recombinant human PEGylated FVIII as recited in instant claim 10.
For claim 15, with respect to where the method is effective to protect the subject from one or both of breakthrough bleeding and spontaneous bleeding for a period of time of at least 48 hours and up to 120 hours:
As stated supra for claim 3, ‘937 does not expressly teach or determine whether the ‘937 ingested swallowable device comprising a composition of FVIII protects the subject from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours.
MPEP 2112-2112.02 states that when a reference discloses all the limitations of a claim except for a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention but has basis for shifting the burden of proof to applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). In the instant case, ‘937 expressly claims the instant treatment method of treating hemophilia A and expressly claims the instant manipulative step of orally (i.e., ingesting) administering a swallowable device comprising a solid dosage form of a composition comprising FVIII where the device is structured to deliver the FVIII into a peritoneal cavity of the subject. Thus, ‘937 claims the instant method, the instant manipulative step, and the instant administered swallowable device. The method being effective to protect the subject from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours would be dependent upon the manner of administration and the structure of the swallowable device.
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants’ swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject differs, and if so to what extent, from the swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject disclosed in ‘937. The cited art taken as a whole demonstrates a reasonable probability that the swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject of ‘937 is either identical or sufficiently similar to the claimed swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject that whatever differences exist are not patentably significant. Therefore, with the showing of the reference, the burden of establishing novelty or non-obviousness by objective evidence is shifted to the Applicants.
Merely because a function of a swallowable device and a manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject is not expressly disclosed in a reference does not make the known method patentable. The instant swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject possess inherent functions which might not be displayed in the tests used in ‘937. Accordingly, the disclosure of ‘937 is a sufficient basis that the swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject inherently would be effective to protect the subject from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours.
In the alternative, even if the claimed swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject are not identical to the ‘937 swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject with regard to some unidentified functions, the differences between that which is disclosed and that which is claimed are considered to be so slight that the ‘937 swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject is likely to inherently possess the same functions of the claimed swallowable device and manipulative step of oral administration and delivery of FVIII into a peritoneal cavity of the subject particularly in view of the similar characteristics which they have been shown to share (i.e., same swallowable device structure and same manipulative step). Thus, the claimed method resulting in the protection of the subject from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours would have been obvious to those of ordinary skill in the art under the meaning of USC 103. Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
For claims 18-20, with respect to where the device comprises multiple payloads or doses of FVIII as recited in instant claim 18; and with respect to where the device is structured to deliver one or more payloads or doses into the peritoneal cavity of the subject at different times as recited in instant claim 19; and with respect to where the device comprises 2, 3, 4, or 5 or more payloads or doses of FVIII as recited in instant claim 20:
‘937 teaches that the device will typically be configured to deliver a single drug as part of a medication, but in some embodiments, the device can be configured for delivery of multiple drugs (See ‘937, [0071]). For embodiments having multiple medications/drugs, the medications can be contained in separate tissue penetrating members or within separate compartments or reservoirs within a capsule (See ‘937, [0071]). In another embodiment, a first dose of medication containing a first drug can be packed into the penetrating member(s) and a second dose of medication (containing the same or a different drug) can be coated onto the surface of the capsule as depicted in Figure 1b (See ‘937, [0071]). The drugs in the two doses of medication can be the same or different (See ‘937, [0071]). In this way, a bimodal pharmacokinetic release of the same or different drugs can be achieved (See ‘937, [0071]). The second dose of medication can have an enteric coating to ensure that it is released in the small intestine and achieve a time release of the medication as well (See ‘937, [0071]).
Furthermore, ‘937 teaches embodiments for the delivery of drugs and other therapeutic agents (in the form of medication) into the walls of the GI tract by using the swallowable drug delivery device (See ‘937, [0092]). One such embodiment includes a hollow needle or other hollow tissue penetrating member where medication delivery is effectuated by using the actuating mechanism to advance the member a selected distance into the mucosa of the intestinal wall, and then the medication is injected through the needle lumen by advancement of the delivery member (See ‘937, [0092]). The delivery member is withdrawn and the member is them withdrawn back within the body of the capsule, e.g., by recoil of the spring, detaching from the intestinal wall (See ‘937, [0092]). Devices can also have multiple needles, a second or third needle, which can be used to deliver additional doses of the same drug or separate drugs (See ‘937, [0092]). Needle or other tissue penetrating member advancement can be done substantially simultaneously or in sequence (See ‘937, [0092]). As such, ‘937 suggests where a capsule can be configured such that it contains more than 1 payload or dose of a drug, e.g., FVIII, where the more than 1 payload includes 2 payloads/doses of the drug, and configured such that the each payload/dose is delivered into the peritoneal cavity at different times, i.e., capsule coating or different needles to deliver a payload/dose in sequence.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to follow the teachings of ‘937 and orally administer to a subject a capsule as a swallowable device containing two to three payloads, each payload containing a composition comprising FVIII that is delivered into the peritoneal cavity of the subject at different times in order to treat hemophilia A in the subject. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because a swallowable device such as a capsule was known to be configured such that a second, and optional third, payload/dose of a drug is delivered into the peritoneal cavity of a subject where such configuration was known to include were a second payload/dose of the same drug is coated on the capsule, or where multiple needles are included in the capsule, each of which contains the additional payload/dose of the same drug as taught by ‘937. One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that a capsule as a swallowable device of ‘937 contains a payload formed from, or containing, a composition comprising FVIII as a CF to be administered orally and delivered into a peritoneal cavity to a subject in order to treat hemophilia A. Therefore, configuring the capsule to contain a second, and optionally, third payload/dose of FVIII such that the FVIII is delivered into the peritoneal cavity in sequence or delivered at different times while within the peritoneal cavity would support the treatment of hemophilia A by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention and/or the use of known technique to improve similar devices (methods, or products) in the same way and/or the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results pursuant to KSR.
Thus, the invention as a whole is prima facie obvious over 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 1-7, 9-10, 13, 15, and 18-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 12-19, and 28-37 of U.S. Patent No. 10,603,275 B2 (cited in the IDS received on 10/27/23); over claims 1-24 and 51 of U.S. Patent No. 11,464,737 B2; over claims 1-19 of U.S. Patent No. 11,826,464 B2; and over claims 1-11 of U.S. Patent No. 12,201,721 B2, each in view of Imran et al. US 2019/0133937 A1 published on May 9, 2019.
10,603,275 B2
‘275 claims:
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(See ‘275 claims 75, 79-80, 87, 89-93, and 104 thereby corresponding to issued claims 1, 5-6, 12, 14-17, and 28, respectively). As such, the ‘275 claimed method satisfies the instant claim limitations with respect to a method of treating hemophilia A by orally administering on a daily basis a swallowable device comprised within a capsule containing a payload formed from, or containing, a composition comprising FVIII in an dosage in the range of 400 to 10,000 IU that has been modified to increase its in vivo circulation and wherein the device is structured to deliver the FVIII into a peritoneal cavity of the subject as recited in instant claims 1-3, 5-7, 9, and 21. As discussed supra for claims 3 and 15, with respect to protecting the subject from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours, since the ‘275 claimed method encompasses the instant manipulative step and the instant swallowable device, it would necessarily follow that the subject will be protected from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours without evidence to the contrary, especially since the PTO cannot perform the necessary experiments to determine if the ‘275 claimed method would result in such protection.
However, ‘275 does not expressly claim where the frequency of administration is once daily as recited in instant claims 1 and 5; where the dose of FVIII ranges from about 30 IU/kg to about 300 IU/kg as recited in instant claims 2 and 13; where the FVIII is a recombinant human PEGylated FVIII as recited in instant claim 10; and with respect to where the device comprises multiple payloads or doses of FVIII as recited in instant claims 18-20.
Please see discussion of ‘937 supra. ‘937 teaches each of these limitations. One of ordinary skill in the art would be motivated with a reasonable expectation of success to administer the swallowable device once daily at a recombinant human PEGylated FVIII dose ranging from 20-100 IU/kg where the device can contain more than 1 payload/dose of the FVIII because FVIII was known to be PEGylated to increase its in vivo half-life; because formulating the device for oral administration allowed for once daily administration; because FVIII was known to be dosed within a range of 20-100 IU/kg depending on the clinical setting for hemophilia A treatment; and because the swallowable device was known to be structured such that two or three payloads/doses of a drug such as FVIII can be delivered to the peritoneal cavity of a subject in sequence. Thus, the ‘275 claimed invention is not patentable distinct from the instant invention.
11,464,737 B2
‘737 claims:
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(See ‘737 claims 1, 5, 8-9, 11-19, and 54 thereby corresponding to issued claims 1, 4, 7-8, 10-17, and 51, respectively). As such, the ‘737 claimed invention satisfies the instant claim limitations with respect to a method of treating a clotting disorder by orally administering a swallowable device comprised within a capsule containing a payload formed from, or containing, a composition comprising FVIII in an dosage in the range of 400 to 10,000 IU that has been modified to increase its in vivo circulation via PEGylation and wherein the device is structured to deliver the FVIII into a peritoneal cavity of the subject as recited in instant claims 1-3, 6-7, 9, and 21. As discussed supra for claims 3 and 15, with respect to protecting the subject from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours, since the ‘737 claimed invention encompasses the instant manipulative step (i.e., oral ingestion and delivery into a peritoneal cavity) and the instant swallowable device, it would necessarily follow that the subject will be protected from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours without evidence to the contrary, especially since the PTO cannot perform the necessary experiments to determine if the ‘737 claimed invention would result in such protection.
Regarding the clotting disorder to be treated is hemophilia A, pursuant to MPEP 804(II)(B)(1), [i]n AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. In the instant case, ‘737 teaches that FVIII is administered for treatment of hemophilia A (See ‘737, col. 29; Table 1). Therefore, the clotting disorder to be treated in ‘737 claim 1 includes hemophilia A when the CF is FVIII.
However, ‘737 does not expressly claim where the frequency of administration is once daily as recited in instant claims 1 and 5; where the dose of FVIII ranges from about 30 IU/kg to about 300 IU/kg as recited in instant claims 2 and 13; and with respect to where the device comprises multiple payloads or doses of FVIII as recited in instant claims 18-20.
Please see discussion of ‘937 supra. ‘937 teaches each of these limitations. One of ordinary skill in the art would be motivated with a reasonable expectation of success to administer the swallowable device once daily at a recombinant human PEGylated FVIII dose ranging from 20-100 IU/kg where the device can contain more than 1 payload/dose of the FVIII because formulating the device for oral administration allowed for once daily administration; because FVIII was known to be dosed within a range of 20-100 IU/kg depending on the clinical setting for hemophilia A treatment; and because the swallowable device was known to be structured such that two or three payloads/doses of a drug such as FVIII can be delivered to the peritoneal cavity of a subject in sequence. Thus, the ‘737 claimed invention is not patentable distinct from the instant invention.
11,826,464 B2
‘464 claims:
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(See ‘434 claims 53-53, 56, 59-60 and 68-70 thereby corresponding to issued claims 1-2, 5, 8-9, and 17-19 respectively). As such, the ‘464 claimed invention satisfies the instant claim limitations with respect to a method of treating a clotting disorder by orally administering a swallowable device comprised within a capsule containing a payload formed from, or containing, a composition comprising FVIII in an dosage in the range of 400 to 10,000 IU and wherein the device is structured to deliver the FVIII into a peritoneal cavity of the subject as recited in instant claims 1-3, 6-7, and 21. As discussed supra for claims 3 and 15, with respect to protecting the subject from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours, since the ‘737 claimed invention encompasses the instant manipulative step (i.e., oral ingestion and delivery into a peritoneal cavity) and the instant swallowable device, it would necessarily follow that the subject will be protected from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours without evidence to the contrary, especially since the PTO cannot perform the necessary experiments to determine if the ‘464 claimed invention would result in such protection.
Regarding the clotting disorder to be treated is hemophilia A, pursuant to MPEP 804(II)(B)(1), [i]n AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. In the instant case, ‘464 teaches that FVIII is administered for treatment of hemophilia A (See ‘464, col. 29; Table 1). Therefore, the clotting disorder to be treated in ‘464 claim 1 includes hemophilia A when the CF is FVIII.
However, ‘464 does not expressly claim where the frequency of administration is once daily as recited in instant claims 1 and 5; where the dose of FVIII ranges from about 30 IU/kg to about 300 IU/kg as recited in instant claims 2 and 13; where the FVIII is a recombinant human PEGylated FVIII as recited in instant claims 9-10; and with respect to where the device comprises multiple payloads or doses of FVIII as recited in instant claims 18-20.
Please see discussion of ‘937 supra. ‘937 teaches each of these limitations. One of ordinary skill in the art would be motivated with a reasonable expectation of success to administer the swallowable device once daily at a recombinant human PEGylated FVIII dose ranging from 20-100 IU/kg where the device can contain more than 1 payload/dose of the FVIII because FVIII was known to be PEGylated to increase its in vivo half-life; because formulating the device for oral administration allowed for once daily administration; because FVIII was known to be dosed within a range of 20-100 IU/kg depending on the clinical setting for hemophilia A treatment; and because the swallowable device was known to be structured such that two or three payloads/doses of a drug such as FVIII can be delivered to the peritoneal cavity of a subject in sequence. Thus, the ‘464 claimed invention is not patentable distinct from the instant invention.
12,201,721 B2
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(See ‘721, claims 78, 55, 58-59, and 62-65 thereby corresponding to issued claims 1, 4, 7-8, 9-11, respectively). As such, the ‘721 claimed method satisfies the instant claim limitations with respect to a method of treating hemophilia A by orally administering a swallowable device comprised within a capsule containing a payload formed from, or containing, a composition comprising FVIII in an dosage in the range of 400 to 10,000 IU and wherein the device is structured to deliver the FVIII into a peritoneal cavity of the subject as recited in instant claims 1-3, 5-7, and 21. As discussed supra for claims 3 and 15, with respect to protecting the subject from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours, since the ‘721 claimed method encompasses the instant manipulative step and the instant swallowable device, it would necessarily follow that the subject will be protected from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours without evidence to the contrary, especially since the PTO cannot perform the necessary experiments to determine if the ‘721 claimed method would result in such protection.
However, ‘721 does not expressly claim where the frequency of administration is once daily as recited in instant claims 1 and 5; where the dose of FVIII ranges from about 30 IU/kg to about 300 IU/kg as recited in instant claims 2 and 13; where the FVIII is a recombinant human PEGylated FVIII as recited in instant claims 9-10; and with respect to where the device comprises multiple payloads or doses of FVIII as recited in instant claims 18-20.
Please see discussion of ‘937 supra. ‘937 teaches each of these limitations. One of ordinary skill in the art would be motivated with a reasonable expectation of success to administer the swallowable device once daily at a recombinant human PEGylated FVIII dose ranging from 20-100 IU/kg where the device can contain more than 1 payload/dose of the FVIII because FVIII was known to be PEGylated to increase its in vivo half-life; because formulating the device for oral administration allowed for once daily administration; because FVIII was known to be dosed within a range of 20-100 IU/kg depending on the clinical setting for hemophilia A treatment; and because the swallowable device was known to be structured such that two or three payloads/doses of a drug such as FVIII can be delivered to the peritoneal cavity of a subject in sequence. Thus, the ‘721 claimed invention is not patentable distinct from the instant invention.
Claims 1-7, 9-10, 13, 15, and 18-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-20 of copending Application No. 17/515,284 (US 2022/0118056 A1) (cited in the IDS received on 10/27/23); and over claims 52-55 and 59-71 of copending Application No. 18/999,928 (US 2025/0195419 A1), each in view of Imran et al. US 2019/0133937 A1 published on May 9, 2019.
17/515,284
‘284 claims:
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(See ‘284 claims 10-13, and 15-17). As such, the ‘284 claimed method satisfies the instant claim limitations with respect to a method of treating a clotting disorder by orally administering a swallowable device containing a payload formed from, or containing, a composition comprising PEGylated FVIII in an dosage above 75 IU/kg body weight of the patient and wherein the device is structured to deliver the FVIII into a peritoneal cavity of the subject as recited in instant claims 1-3, 9-10, and 13. As discussed supra for claims 3 and 15, with respect to protecting the subject from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours, since the ‘284 claimed method encompasses the instant manipulative step and the instant swallowable device, it would necessarily follow that the subject will be protected from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours without evidence to the contrary, especially since the PTO cannot perform the necessary experiments to determine if the ‘284 claimed method would result in such protection.
However, ‘284 does not expressly claim where the clotting disorder to be treated in hemophilia A as recited in instant claims 1-3; where the frequency of administration is once daily as recited in instant claims 1 and 5; where the dose of FVIII ranges from about 1000 IU to about 12,000 IU as recited in instant claims 6-7; with respect to where the device comprises multiple payloads or doses of FVIII as recited in instant claims 18-20; and with respect to where the device is comprised within a capsule as recited in instant claim 21.
Please see discussion of ‘937 supra. ‘937 teaches each of these limitations. One of ordinary skill in the art would be motivated with a reasonable expectation of success to administer the swallowable device once daily containing a recombinant human PEGylated FVIII dose ranging from about 400 to 10,000 IU where the device can contain more than 1 payload/dose of the FVIII because FVIII was known to administered to treat hemophilia A; because formulating the device for oral administration allowed for once daily administration; because FVIII was known to be dosed within a range of about 400 to 10,000 IU for hemophilia A treatment; and because the swallowable device was known to be structured in a capsule such that two or three payloads/doses of a drug such as FVIII can be delivered to the peritoneal cavity of a subject in sequence. Thus, the ‘284 claimed invention is not patentable distinct from the instant invention.
18/999,928
‘928 claims:
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(See ‘928 claims 52, 55, 61, 63, and 65). As such, the ‘928 claimed method satisfies the instant claim limitations with respect to a method of treating hemophilia A by orally administering a swallowable device such as a capsule containing a payload formed from, or containing, a composition comprising FVIII wherein the device is structured to deliver the FVIII into a peritoneal cavity of the subject as recited in instant claims 1-3 and 21. As discussed supra for claims 3 and 15, with respect to protecting the subject from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours, since the ‘928 claimed method encompasses the instant manipulative step and the instant swallowable device, it would necessarily follow that the subject will be protected from spontaneous breakthrough bleeding for at least 48 hours and up to 120 hours without evidence to the contrary, especially since the PTO cannot perform the necessary experiments to determine if the ‘928 claimed method would result in such protection.
However, ‘928 does not expressly claim where the frequency of administration is once daily as recited in instant claims 1 and 5; where the dose of FVIII ranges from about 30 IU/kg to about 300 IU/kg as recited in instant claims 2 and 13; where the dose of FVIII ranges from about 1000 IU to about 12,000 IU as recited in instant claims 6-7; with respect to where the FVIII is PEGylated as recited in instant claims 9-10; and with respect to where the device comprises multiple payloads or doses of FVIII as recited in instant claims 18-20.
Please see discussion of ‘937 supra. ‘937 teaches each of these limitations. One of ordinary skill in the art would be motivated with a reasonable expectation of success to administer the swallowable device once daily containing a recombinant human PEGylated FVIII dose ranging from about 400 to 10,000 IU or from about 20-100 IU/kg body weight, where the device can contain more than 1 payload/dose of the FVIII because formulating the device for oral administration allowed for once daily administration; because FVIII was known to be PEGylated to increase its in vivo half-life; because FVIII was known to be dosed within a range of about 400 to 10,000 IU or 20-100 IU/kg body weight for hemophilia A treatment; and because the swallowable device was known to be structured in a capsule such that two or three payloads/doses of a drug such as FVIII can be delivered to the peritoneal cavity of a subject in sequence. Thus, the ‘928 claimed invention is not patentable distinct from the instant invention.
These are provisional nonstatutory double patenting rejections.
Conclusion
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654
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