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 .
DETAILED ACTION
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election of Group II, claims 18-21 and new claims 22-24, in the reply filed on Jul. 7, 2025 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)).
Claims 18-24 remain pending in the current application, cancelled claims 2-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claims 18-24 have been considered on the merits.
Status of the Claims
Claims 18-24 are currently pending.
Claim 18 is amended.
Claims 1-17 are cancelled.
New claims 22-24 have been added.
Claims 18-24 have been considered on the merits.
Claim Objections
The disclosure is objected to because of the following informalities:
Claim 19 is objected to in the recitation of “wherein the age-related disorder is osteoporosis, arthrosis, glucose intolerance, insulin resistance, reduced heart, circulatory, or lung function, cardiovascular disease, a neurodegenerative disease, loss of memory, loss of neuromuscular coordination, or decrease of longevity”, and in the interest of improving claim form, it is suggested that the recited phrase be amended to recite “wherein the age-related disorder is osteoporosis; arthrosis; glucose intolerance; insulin resistance; reduced heart, circulatory, or lung function; cardiovascular disease; a neurodegenerative disease; loss of memory; loss of neuromuscular coordination; or decrease of longevity”. It is suggested to change the majority of the commas to semi-colons to clarify that the phrase “reduced heart, circulatory, or lung function” is one of the listed age-related disorders.
Appropriate correction is appreciated.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a limited number of age-related disorders (reducing fine lines and wrinkles, improving hair growth, treating bone fractures in the spine, treating osteoporosis, treating osteopenia, improving fertility in a female, treating progressive cerebellar ataxia, treating metastatic renal-cell carcinoma, treating Type 1 diabetes, and treating dry macular degeneration) in a human subject by administering an effective amount of a cell product containing an isolated population of human peripheral blood derived pluripotent stem cells (PBD-PSCs), does not reasonably provide enablement for any other embodiment including the administration of an isolated population of parathyroid hormone type 1 receptor (PTH1R) positive pluripotent stem cell transfected with human telomerase reverse transcriptase (hTERT) in any amount and administered by any means to any subject with any age-related disorder. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, the enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of treating an age-related disorder by administering an isolated population of parathyroid hormone type 1 receptor (PTH1R) positive pluripotent stem cell that is transfected with human telomerase reverse transcriptase (hTERT). Thus, the claims taken together with the specification imply that any age-related disorder in any species of subject can be treated with the instantly claimed method of administering an isolated population of parathyroid hormone type 1 receptor (PTH1R) positive pluripotent stem cell that is transfected with human telomerase reverse transcriptase (hTERT) in any amount and administered by any means.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The state of the prior art of cell therapy for treating age-related disorders was highly unpredictable before the effective filing date of the claimed invention. While cell therapy has been used to treat numerous age-related disorders, cell therapy in general continues to be unpredictable as supported by numerous teachings available in the art.
For instance, Jiang et al. (Cell and Tissue Banking, 2020) reports with respect to cell therapy for vascular dementia (an age-related disorder) that the selection of cell source is critical for cell therapy to be successful and that there is no consensus on the best source of cells, timing, location, route and therapeutic doses of the transplantation and that efforts for determining how to get transplanted cells to the target location and to survive there are need (pg. 350 Col. 1 last para. and pg. 357 to pg. 358 para. 2). Additionally, Jiang reports due to differences between species, animal research results may not be successfully translated into clinical applications (pg. 353 Col. 2 last para. and pg. 357 Col. 1). Guo et al. (Signal Transduction and Targeted Therapy, 2022) states, “Aging is a ubiquitous biological process that results in a progressive and irreversible decline in physical function across all organ systems that is induced by the accumulation of damage in response to a variety of stressors” (pg. 1 para. 1). Guo further reports the on the numerous molecular mechanisms of aging (pg. 2-8 and Fig. 5-7). In addition, Guo reports the details some of the various different causes and mechanisms of aging-related diseases such as Alzheimer’s disease, Parkinson’s disease, heart failure, atherosclerosis, type 2 diabetes mellitus, nonalcoholic fatty liver disease, osteoarthritis, osteoporosis, chronic obstructive pulmonary disease, benign prostatic hyperplasia, aging-related macular degeneration, presbycusis, and cancer (pg. 9-17)
Thus, as the state of the art stands, treatment of an age-related disorder by cell therapy is highly unpredictable depending on many factors including the disorder and cause of the disorder, the species being treated, the dosage and mode of administration of the cell therapy.
(5) The relative skill of those in the art:
The relative skill of those in the art is high.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The instant specification provides working examples and guidance for methods treating particular age related disorders in only one subject or at most two subjects by administering an undisclosed amounts. Specifically, the specification provides examples which include hair loss or improving reducing fine lines and wrinkles (Example 5), increasing hair growth (Example 6), treating a bone fracture in the spine (Example 7), treating osteoporosis (Examples 8 and 9), treating osteopenia (Example 11), improving fertility in a female (Example 11), treating progressive cerebellar ataxia (Example 12), treating metastatic renal-cell carcinoma (Example 13), treating Type 1 diabetes (Example 14), and treating dry macular degeneration (Example 15). The human subjects in these all of these examples except for Example 12 were treated with PBD-PSCs. In Example 12, the subject was treated with isolated PTH1R positive PBD-PSCs. However, the specification does not provide any guidance for a method treating any age-related disorder with an isolated population of PTH1R positive pluripotent stem cell that is transfected with hTERT in any amount and administered by any means. The applicants have provided neither data nor any mechanism of action for the claimed method to give the skilled artisan any reason to expect that any PTH1R positive pluripotent stem cell transfected with hTERT would be effective in treating all age-related disorders. There is no examples or data for arthrosis; other intolerance and insulin resistance than Type 1 diabetes; reduced heart, circulatory or lung function; cardiovascular diseases; loss of memory; other losses of neuromuscular coordination than progressive cerebellar ataxia; decrease of longevity; or osteoarthritis. Additionally, there are no examples of reducing telomere shortening, increasing cellular self-renewal, increasing lifespan, or reducing aging.
Claims to methods of treatment generally require supporting data because of the unpredictability in biological responses to therapeutic treatments. The efficacy of cell therapy faces numerable unfavorable obstacles in vivo. As such, in vivo utility necessarily involves unpredictability with respect to physiological activity of an asserted process in humans. For example, the delivery of cells in amounts needed to be efficacious, but not lethal to the subject requires testing in order to adequately determine the proper human dosage. Thus, claims to treating an age-related disorder by cell therapy may be unbelievable in the absence of strong supporting evidence. There is no conclusive evidence in the instant disclosure to indicate that the instantly claimed method would have a benefit in the treatment of all age-related disorders.
In the instant case, the applicants have provided only specific examples of individual human subjects with different disorders treated with undisclosed amounts of cells. The high degree of unpredictability associated with the claimed method underscores the need to provide teachings in the specification that would provide the skilled artisan with specific amounts and modes of delivery for the particular age-related disordered that is being treated and subjects other than human. There appears to be no basis for extending or generalizing the results described in the specification with respect to other subjects, other age-related diseases, and with claimed cells, any PTH1R positive pluripotent stem cell that is transfected with hTERT, and the art suggests that cell therapy is generally unpredictable.
(8) The quantity of experimentation necessary:
The test of enablement is not whether any experimentation is necessary, but whether, it any experimentation is necessary, it is undue. Due to the large quantity of experimentation necessary to establish whether any PTH1R positive pluripotent stem cell that is transfected with hTERT would be effective in treating all age-related disorders in any species of subject would require undue experimentation for one skilled in the art at the time of the invention to practice over the full scope of the invention claimed. Considering the state of the art as discussed above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the claimed invention within the broad scope as instantly claimed.
It is the examiner’s position that one skilled in the art could not practice the invention commensurate in the scope of the claims without undue experimentation. It is also noted, considering the unpredictability in the art with regarding to cell therapy treatments for age-related disorders, that the treating of an age-related disorder is not enablement for any other embodiment than treating the age-related disorders given in the Examples in the specification (reducing fine lines and wrinkles, improving hair growth, treating bone fractures in the spine, treating osteoporosis, treating osteopenia, improving fertility in a female, treating progressive cerebellar ataxia, treating metastatic renal-cell carcinoma, treating Type 1 diabetes, and treating dry macular degeneration) in a human subject by administering an effective amount of a cell preparation containing a population of isolated human PBD-PSCs.
Considering the state of the art as discussed above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the claimed invention within the broad scope as instantly claimed. Therefore, claims 18-24 are rejected under 35 U.S.C. 112, first paragraph, for scope of enablement.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp
Claims 18-22 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3 and 7 of U.S. Patent No. 11,103,537. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the issue patent. In addition, both claim methods of treating an age-related disorder by administering to the subject a composition containing an isolated population of parathyroid hormone (PTH) receptor-positive pluripotent stem cells transfected with human telomerase reverse transcriptase (nTERT).
The limitations of instant claim 18 are recited by claim 1 of US Patent No. 11,103,537 recites a method of treating an age-related disorder by administering to the subject a composition containing an isolated population of parathyroid hormone (PTH) receptor-positive pluripotent stem cells transfected with human telomerase reverse transcriptase (nTERT). Although the claim does not explicitly state identifying a subject having an age-related disorder this would be inherent to the method of treating an age-related disorder.
The limitations of the instant claim 19 of the type of age-related disorder is recited by claim 3 of US Patent No. 11,103,537.
The limitation of the instant claim 20 of the administration of the composition reduces telomere shortening, increases cellular self-renewal, increases lifespan, reduces fine lines or wrinkles, or reduces aging in the subject disorder is recited by claim 2 of US Patent No. 11,103,537.
The limitation of the instant claim 21 of where the composition is administered to the subject once weekly, once monthly or once annually is recited by claim 7 of US Patent No. 11,103,537.
The limitations of the instant claim 22 of where the age-related disorder is osteoporosis is recited by claim 3 of US Patent No. 11,103,537.
Claims 23 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 7 of U.S. Patent No. 11,103,537 (as applied to claims 18-22) in view of Sackstein (US 2016/0184367 A1).
The limitations of instant claim 18 are recited by claim 1 of US Patent No. 11,103,537 recites a method of treating an age-related disorder by administering to the subject a composition containing an isolated population of parathyroid hormone (PTH) receptor-positive pluripotent stem cells transfected with human telomerase reverse transcriptase (nTERT).
The claims of US Patent No. 11,103,537 do not recite the limitations of where the age-related disorder is osteopenia or osteoarthritis as recited in claims 23 and 24, respectively.
Sackstein teaches a method of treating disorders with acute and/or chronic inflammation symptoms with cell therapy where the disorder includes osteopenia and osteoarthritis (abstract, 0002, and 0101)
In view of the benefit of treating additional known age-related disorders, it would have been obvious to one of ordinary skill in the art to include the additional age-related disorders, osteopenia or osteoarthritis, taught by Sackstein in the method of cell therapy of US Patent No. 11,103,537.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632